NA 204.816Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886982146267), received between Feb 5, 2018 and Nov 19, 2024 — classified as 36 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT ON (B)(6), 2024 A REVISION OCCURRED DUE TO PAIN. THE PATIENT'S ORIGINAL SURGERY WAS A RIGHT ULNA ORIF ON (B)(6) 2021. DURING THE REMOVAL IT WAS DISCOVERED MULTIPLE SCREWS WERE RUSTED. SCREWS WERE REMOVED. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20723437 ↗
• InjuryNov 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT ON (B)(6) 2024 A REVISION OCCURRED DUE TO PAIN. THE PATIENT'S ORIGINAL SURGERY WAS A RIGHT ULNA ORIF ON (B)(6) 2021. DURING THE REMOVAL IT WAS DISCOVERED MULTIPLE SCREWS WERE RUSTED. SCREWS WERE REMOVED. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20722878 ↗
• InjuryNov 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT ON (B)(6) 2024 A REVISION OCCURRED DUE TO PAIN. THE PATIENT'S ORIGINAL SURGERY WAS A RIGHT ULNA ORIF ON (B)(6) 2021. DURING THE REMOVAL IT WAS DISCOVERED MULTIPLE SCREWS WERE RUSTED. SCREWS WERE REMOVED. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20722795 ↗
• InjuryNov 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT ON (B)(6) 2024 A REVISION OCCURRED DUE TO PAIN. THE PATIENTS ORIGINAL SURGERY WAS A RIGHT ULNA ORIF ON (B)(6) 2021 . DURING THE REMOVAL IT WAS DISCOVERED MULTIPLE SCREWS WERE RUSTED. SCREWS WERE REMOVED . PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20722489 ↗
• InjuryJun 21, 2023Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5117888. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS FURTHER REPORTED THAT THERE WERE A TOTAL OF THREE SCREWS INVOLVED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS REPORTED. (B)(4) IS RELATED TO (B)(4), WHICH REPORTS AN ADDITIONAL SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17170001 ↗
• InjuryJun 21, 2023Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5117888, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS FURTHER REPORTED THAT THERE WERE A TOTAL OF THREE SCREWS INVOLVED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS REPORTED. (B)(4) IS RELATED TO (B)(4), WHICH REPORTS AN ADDITIONAL SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17170000 ↗
• InjuryJun 21, 2023Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5117888, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS FURTHER REPORTED THAT THERE WERE A TOTAL OF THREE SCREWS INVOLVED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS REPORTED. (B)(4) IS RELATED TO (B)(4), WHICH REPORTS AN ADDITIONAL SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17169995 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH AFRICA AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2022, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION FOR A CLOSED ULNA FRACTURE USING A SEMI TUBULAR PLATE AND 3.5 MM CORTICAL SCREWS. THE SURGERY WAS UNEVENTFUL AND SO WAS THE POST-OPERATIVE FOLLOW-UP. IN (B)(6) 2022, THE PATIENT PRESENTED WITH REDNESS AND PAIN OVER THE SURGERY SITE. THE PLATE WAS SUBSEQUENTLY REMOVED. THE FRACTURE WAS UNITED, AND SAMPLES WERE TAKEN FOR INFECTION CULTURE AS THE SURGEON SUSPECTED POSSIBLE SURGICAL SITE INFECTION. THE SURGEON NOTICED WHAT APPEARED LIKE A RUST-LIKE RESIDUE ON THE TWO SCREW HOLES IN THE PLATE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ORAL ANTIBIOTICS. THE PATIENT WILL BE FOLLOWED UP WITH IN TWO WEEKS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: TRAUMA. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 15833169 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY NOVEMBER 03, 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1)3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779077 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1)3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779062 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON PERFORMED A REMOVAL OF HARDWARE DUE TO PAIN AND IRRITATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 12 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628638 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779581 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE HARDWARE IN QUESTION WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN WHEN THE HARDWARE WAS ORIGINALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 8 OF 11 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12489396 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 2.7 LOCKING SCREW SLF-TPNG T8 SD REC 16. THIS REPORT IS 11 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873614 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 42MM. THIS REPORT IS 3 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873580 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11164203 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11163145 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 2 OF 8 FOR (B)(4). ADDITIONAL DEVICE ARE CAPTURED UNDER RELATED (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11135745 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4). ADDITIONAL DEVICE ARE CAPTURED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11135737 ↗
• MalfunctionJan 7, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT RADIAL SHAFT OPEN REDUCTION EXTERNAL FIXATION (ORIF). THE SURGEON HAD REDUCED THE FRACTURE AND PLACED THE PLATE ON. THEN, THE SURGEON DRILLED WITH A 2.5 MM DRILL FOR A 3.5 CORTEX SCREW. THE SURGEON ATTEMPTED TO INSERT TWO 16MM SCREWS AND THE SCREWS WOULD NOT THREAD INTO THE HOLE. THE SURGEON PROCEEDED AND TRIED DIFFERENT SCREWS. FINALLY, THE SURGEON TRIED A THIRD 16 MM SCREW AND IT INSERTED. THE SCREWS ACTED AS IF THEY WERE NOT SELF-TAPPING AND WOULD JUST SPIN. THERE WAS TEN (10) MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: DRILL BIT: (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1) THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135466 ↗
• MalfunctionJan 7, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT RADIAL SHAFT OPEN REDUCTION EXTERNAL FIXATION (ORIF). THE SURGEON HAD REDUCED THE FRACTURE AND PLACED THE PLATE ON. THEN, THE SURGEON DRILLED WITH A 2.5 MM DRILL FOR A 3.5 CORTEX SCREW. THE SURGEON ATTEMPTED TO INSERT TWO 16MM SCREWS AND THE SCREWS WOULD NOT THREAD INTO THE HOLE. THE SURGEON PROCEEDED AND TRIED DIFFERENT SCREWS. FINALLY, THE SURGEON TRIED A THIRD 16 MM SCREW AND IT INSERTED. THE SCREWS ACTED AS IF THEY WERE NOT SELF-TAPPING AND WOULD JUST SPIN. THERE WAS TEN (10) MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: DRILL BIT: (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1) THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135428 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 6MM (PART NUMBER 201.356.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM (PART NUMBER 201.362.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 16MM (PART NUMBER 201.366.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART NUMBER 201.368.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM (PART NUMBER 201.370.97, LOT UNKNOWN, QUANTITY 1), 2.0MM LCP(TM) PLATE 4 HOLES/31MM (PART NUMBER 247.344, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 20MM (PART NUMBER 204.8

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10442706 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 4 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705726 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 3 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705724 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT AN ANKLE ARTHROSCOPY, SYNOVECTOMY, OSTEOTOMY, OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FIBULA BECAUSE ONE OF THE SCREWS HAD FRACTURED WHICH HAD CAUSED PAIN AND FURTHER INJURY TO HER RIGHT LEG. ON (B)(6) 2019, THE PATIENT WENT TO THE ER BECAUSE OF ONGOING RIGHT FOOT NUMBNESS, LOSS OF SENSATION POST RIGHT FOOT SURGERY. THE PATIENT HAS BEEN SEEN BY THE ER PHYSICIAN AND WAS CLEARED STABLE TO DISCHARGE. THIS REPORT IS FOR 5 OF 8 FOR (B)(4). RELATED INCIDENT: (B)(4).

  Patient problems: Hypoesthesia

  MAUDE report 9225433 ↗