OsteoMed 211-2005Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00845694002424), received between Dec 27, 2022 and Jan 8, 2024 — classified as 96 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (76 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 96 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466346 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466344 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466327 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466305 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466301 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466277 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466269 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE 17 OCTOBER 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466268 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 22 DECEMBER 2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

  Patient problems: Failure of Implant

  MAUDE report 18466266 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 2 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263583 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 6 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263543 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 1 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263530 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 3 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263529 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN JUNE 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 4 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263528 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 8 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263519 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 7 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263518 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS AND PLATES WERE SUBSEQUENTLY EXPLANTED. REPORT 5 OF 10 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263516 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS WERE REMOVED, AND THE PLATES WERE "FIXED" WITH LARGER SCREWS. REPORT 1 OF 2 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263506 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY OCCURRED ON (B)(6) 2023, AND IN (B)(6) 2023 (EVENT DATE UNKNOWN), AFTER RADIOGRAPHIC EXAMINATION, IT WAS REPORTED THAT THE FIXATION SCREWS ON THE PATIENT'S RIGHT SIDE OF THE MOUTH WERE LOOSE. IT WAS REPORTED THE SCREWS WERE REMOVED, AND THE PLATES WERE "FIXED" WITH LARGER SCREWS. REPORT 2 OF 2 FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 18263505 ↗
• InjuryNov 30, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN IMPLANTED PLATE BROKE POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING EVENT DATE, DEVICE INFORMATION, AND PATIENT STATUS COULD BE OBTAINED DESPITE MULTIPLE FOLLOW UP ATTEMPTS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18242848 ↗
• 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 34 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049531 ↗
• 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 49 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049530 ↗
• 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 43 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049509 ↗
• 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 42 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049508 ↗
• 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 38 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049507 ↗