OsteoMed 211-1605Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00845694002370), received between Jun 6, 2022 and Dec 27, 2022 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (24 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 16 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049564 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 11 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049551 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 14 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049549 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 23 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049548 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 10 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049547 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 15 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049545 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 4 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049532 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 9 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049502 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022.THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 13 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049501 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 12 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049500 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 22 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049499 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 6 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049498 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022(EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022.THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 21 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049496 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 17 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049495 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 8 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049494 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 24 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049459 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 18 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049456 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND ON (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(4) HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6)2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 1 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049455 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND 04 OCTOBER 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022.THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 5 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049454 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 19 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049453 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 7 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049451 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 2 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049450 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6)2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 20 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049449 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE PORTUGUESE HOSPITAL FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6)2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 3 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049448 ↗
• MalfunctionJun 6, 2022Break; Break

  DURING A FRONTAL CRANIOPLASTY PROCEDURE ON (B)(6) 2022, IT WAS REPORTED THAT THE HEADS OF TWO (2) SCREWS BROKE. THE STEMS OF THE SCREWS WERE REMOVED FROM THE PATIENT AND NEW SCREWS WERE INSERTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND THE PROCEDURE WAS DELAYED BY "ONLY A FEW MINUTES." THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2022-00029 WHICH IS FOR THE OTHER SCREW INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605674 ↗