NA 04.005.528Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982085962), received between Jan 3, 2018 and Dec 23, 2025 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2025 DUE TO OSTEOMYELITIS. PATIENT ALSO PRESENTED WITH EXPOSURE OF THE SCREWS IN THE ANKLE CAUSING SOFT TISSUE INJURY. THE PATIENT REMAINS UNDER MANAGEMENT FOR IRRIGATION AND EVALUATION FOR POSSIBLE AMPUTATION DEPENDING ON THE EVOLUTION OF THEIR VASCULAR CONDITION. DATE OF IMPLANT: (B)(6) 2024. DATE OF EXPLANT: (B)(6) 2025.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23875882 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT CAME IN FROM AN OUTSIDE INSTITUTION WITH A NON UNION OF THE FEMUR FOR A REVISION SURGERY. SURGEON REMOVED ALL IMPLANTS INCLUDING NAIL, AND 4 SCREWS. SURGEON REVISED FEMUR FRACTURE SITE, AND REINSERTED NAIL THAT WAS INITIALLY PLACED WITH NEW SCREWS. REVISION SURGERY COMPLETED SUCCESSFULLY. ORIGINAL IMPLANT DATE WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17512259 ↗
• InjuryOct 25, 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 PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666635 ↗
• InjuryOct 25, 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 PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666628 ↗
• InjuryOct 25, 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 PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666597 ↗
• InjuryOct 25, 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 PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666591 ↗
• InjuryOct 25, 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 PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666582 ↗
• InjuryOct 25, 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 PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666572 ↗
• InjuryOct 3, 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 PATIENT UNDERWENT REVISION SURGERY FOR A NON-UNION FEMORAL NECK FRACTURE. THE TFNA, BLADE, AND 5MM DISTAL INTERLOCK SCREW WERE REMOVED. ANOTHER NAIL WAS INSERTED. THERE WAS NO POST-OP DEVICE MALFUNCTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15531250 ↗
• InjuryJul 28, 2022Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PFNA NAIL AND ONE DISTAL SCREW WERE BROKEN. PER THE PATIENT, NO INCIDENT LIKE A FALL HAD OCCURRED. A REVISION PROCEDURE WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 15122123 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Loss of Range of Motion

  MAUDE report 15093481 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Pain

  MAUDE report 15053288 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS REMOVAL OF TIBIAL NAIL DUE TO INFECTION. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED.

  Patient problems: Unspecified Infection

  MAUDE report 14119453 ↗
• InjuryMar 29, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TFNA HARDWARE WAS REMOVED DUE TO THE IMPLANT FAILING. THE IMPLANT HAD CUT THROUGH AND HAD CREATED AN ULCER ON THE PATIENT¿S LATERAL SIDE. THE IMPLANT WAS INTACT AND NO FRAGMENTS WERE CREATED. THE PATIENT WAS REVISED WITH A TOTAL HIP ARTHROPLASTY (THA). THIS REPORT INVOLVES ONE (1) 3.7MM CANNULATED LOCKING SCREW 38MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Ulcer

  MAUDE report 13940163 ↗
• InjuryMar 1, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE TWO (2) 5.0MM INTERLOCKING SCREWS WERE REMOVED. THE REVISION PROCEDURE WAS PERFORMED DUE TO CORRECTION OF ROTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 13637404 ↗
• InjuryMar 1, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE TWO (2) 5.0MM INTERLOCKING SCREWS WERE REMOVED. THE REVISION PROCEDURE WAS PERFORMED DUE TO CORRECTION OF ROTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 13637381 ↗
• InjuryFeb 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, PATIENT UNDERWENT A REMOVAL OF NAIL DUE TO NONUNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13560192 ↗
• InjuryAug 23, 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 FOR A REMOVAL SURGERY. DURING THE SURGERY, ALL DEVICES WERE INTACT, NO ITEMS WERE BROKEN, AND WERE REMOVED SUCCESSFULLY AND WITHOUT DIFFICULTY. ORIGINALLY, THE PATIENT UNDERWENT FOR REMOVAL HARDWARE OF A LEFT TIBIAL SHAFT FRACTURE FOR INFECTION ON (B)(6) 2020. THE CURRENT REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS FIN POSTOPERATIVELY. THIS COMPLAINT INVOLVES 13 DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS. THIS REPORT IS 1 OF 13 FOR (B)(4).

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

  MAUDE report 12356590 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE PATIENT UNDERWENT THE REMOVAL OF IMPLANTS DUE TO AN INFECTED NONUNION OF THE RIGHT TIBIA. ALL DEVICES WERE REMOVED SUCCESSFULLY. THERE WERE NO BROKEN IMPLANTS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12204484 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA HELICAL BLADE, TFNA END CAP, AND LOCKING SCREW DUE TO THE FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY AND NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11925458 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF NAILING DUE TO NON-UNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS FOR 1 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11924735 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF NAILING DUE TO NON-UNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(6).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11924730 ↗
• InjuryDec 21, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT SHOWED IN THE OFFICE COMPLAINING OF HIP PAIN AND IT WAS THOUGHT THAT SHE HAD FALLEN. THE X-RAY SHOWED THAT THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) THAT WAS IMPLANTED ON (B)(6) 2020, HAD CUT OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE TOTAL HIP REPLACEMENT. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE (PART NUMBER 04.037.244S, LOT 34P7508, QUANTITY 1), TFNA FENESTRATED SCREW 95MM ¿ STERILE (PART NUMBER 04.038.195S, LOT H359691, QUANTITY 1). THIS REPORT INVOLVES 1 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11050250 ↗
• InjuryJun 2, 2020Adverse 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 REVISION AND HARDWARE REMOVAL. THE REVISION SURGERY WAS DUE TO INFECTION AND NON-UNION OF TWO (2) CORTEX SCREWS, ONE (1) TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND, FOUR (4) TITANIUM LOCKING SCREW AND ONE (1) TITANIUM END CAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5 MM CORTEX SCREW SELF-TAPPING 40 MM (PART NUMBER 204.84, LOT UNKNOWN, QUANTITY 1), 3.5 MM CORTEX SCREW SELF-TAPPING 44 MM (PART NUMBER 204.844, LOT UNKNOWN, QUANTITY 1), 10 MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345 MM-STERILE (PART NUMBER 04.034.449S, LOT 22P4336, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 34 MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 40 MM FOR IM NAILS (PART NUMBER 04.005.530, LOT UNKNOWN, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 36 MM FOR IM NAILS (PART NUMBER 04.005.526, LOT UNKNOWN, QUANTITY 1), TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX (PART NUMBER 04.004.000, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 38 MM

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

  MAUDE report 10108230 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) DUE TO A NON-UNION OF THE INTERTROCHANTERIC FEMUR FRACTURE. THE SURGEON SUCCESSFULLY REMOVED THE HARDWARE AND REPLACED THE DEVICE TO A DYNAMIC CONDYLAR SCREW (DCS) AND 95 DEG DCS PLATE 8 HOLE WITH AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE OF RIGHT FEMUR. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9035389 ↗