NA 214.832Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982154651), received between May 4, 2018 and Jul 3, 2023 — classified as 21 injuries.

The most frequently reported specific device problem is “Break” (2 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17247589 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17247219 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2020, AN X-RAY OF FEMUR REPORT AND REVEALED A CLOSED COMMINUTED SUPRACONDYLAR FRACTURE OF LEFT FEMUR WITH NONUNION. DOI: (B)(6) 2019; DOE: (B)(6) 2020; LEFT FEMUR. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 12 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16724071 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE MEDICAL RECORDS RECEIVED ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL FEMUR FRACTURE DUE TO RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE. ON (B)(6) 2022 THE PATIENT HAD A REVISION DUE TO NONUNION RIGHT DISTAL FEMUR SHAFT FRACTURE ABOUT TOTAL KNEE ARTHROPLASTY (TKA). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 3 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16717991 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS SUBMITTED AS PART OF AN INVESTIGATOR INITIATED STUDY (IIS) FOR THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA). IT WAS REPORTED THAT A PATIENT WAS PRESENTED AFTER A MOTOR VEHICLE CRASH WITH A LEFT OPEN DISTAL FEMUR FRACTURE ON (B)(6) 2021 AND WAS OPERATED ON WITH RFNA INTRAMEDULLARY NAIL ON (B)(6) 2021. PATIENT WAS DIAGNOSED WITH INFECTION OF HER HARDWARE/SEPTIC NONUNION ON (B)(6) 2021. PATIENT UNDERWENT DEBRIDEMENT AND EXCHANGE OF HARDWARE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15643865 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 6 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14654528 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 4 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14654332 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 5 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 14654292 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 2 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14654133 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HARDWARE FROM DISTAL FEMUR DUE TO PAIN. THERE WAS NO SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1)4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12779832 ↗
• InjuryJan 13, 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 REMOVAL AND REVISION OF HARDWARE DUE TO FALL. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS REPORT IS 9 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165128 ↗
• InjuryJan 13, 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 REMOVAL AND REVISION OF HARDWARE DUE TO FALL. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS REPORT IS 4 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165095 ↗
• 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) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 4 OF 8 FOR (B)(4). ADDITIONAL DEVICE ARE CAPTURED UNDER RELATED (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11135801 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643142 ↗
• InjuryApr 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF PROXIMAL FEMUR. ON THE FINAL TIGHTENING A 4.5MM CORTEX SCREW HEAD BROKE OFF. THE SCREW HEAD WAS REMOVED BUT THE SCREW SHAFT WAS RETAINED. A SCREWDRIVER WAS USED TO TAP THE SCREW SHAFT THROUGH THE NEAR CORTEX OUT OF THE PATH FOR A FUTURE SCREW. ONCE THE SHAFT WAS CLEARED, A NEW SCREW WAS PLACED INTO THE SAME SCREW HOLE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS STABLE. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT CAPTURES THE INTRA-OPERATIVE EVENT WHILE (B)(4) CAPTURES THE POST-OPERATIVE EVENT.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8522888 ↗
• InjuryMar 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT EXTRACTION LOCKING COMPRESSION PLATE (LCP) 4.5 DUE TO SCREW RUPTURE AND FAILURE. THE SURGEON REMOVED SOME BROKEN ONE (1) 4.5/32 MM CORTEX SCREW SELF-TAPING AND ONE (1) 4.5/34 MM CORTEX SCREW SELF-TAPPING FROM THE LCP PLATE. THE PLATE WAS INTACT, AND TWO NEW SCREWS WERE REPLACED BY A CABLE SYSTEM. THE PATIENT EXPERIENCED PAIN AND INSTABILITY TOWARDS THE BROKEN SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS OKAY. CONCOMITANT DEVICES: LOCKING COMPRESSION PLATE (PART/LOT UNKNOWN, QUANTITY 1); SCREWS (PART/LOT UNKNOWN, QUANTITY 5). THIS REPORT IS FOR A CORTEX SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8387294 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679735 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679728 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679716 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679702 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7487830 ↗