NA 04.005.526Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982085948), received between Mar 26, 2019 and Dec 23, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 21 most recent of 21 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 23875863 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NONUNION OF THE FEMUR FROM A PREVIOUS SURGERY. THE SURGEON REMOVED THE NAIL AND SCREWS THAT WERE PLACED DURING PRIMARY SURGERY. THE SURGEON CLEANED OUT THE NONUNION SITE, PERFORMED A RIA PROCEDURE TO OBTAIN A BONE GRAFT, PLACED A NEW NAIL AND THE BONE GRAFT AND THEN COMPRESSED THE NONUNION SITE WITH A LARGE FRAGMENT PLATE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17962085 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NONUNION OF THE FEMUR FROM A PREVIOUS SURGERY. THE SURGEON REMOVED THE NAIL AND SCREWS THAT WERE PLACED DURING PRIMARY SURGERY. THE SURGEON CLEANED OUT THE NONUNION SITE, PERFORMED A RIA PROCEDURE TO OBTAIN A BONE GRAFT, PLACED A NEW NAIL AND THE BONE GRAFT AND THEN COMPRESSED THE NONUNION SITE WITH A LARGE FRAGMENT PLATE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17961731 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NONUNION OF THE FEMUR FROM A PREVIOUS SURGERY. THE SURGEON REMOVED THE NAIL AND SCREWS THAT WERE PLACED DURING PRIMARY SURGERY. THE SURGEON CLEANED OUT THE NONUNION SITE, PERFORMED A RIA PROCEDURE TO OBTAIN A BONE GRAFT, PLACED A NEW NAIL AND THE BONE GRAFT AND THEN COMPRESSED THE NONUNION SITE WITH A LARGE FRAGMENT PLATE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17961729 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NONUNION OF THE FEMUR FROM A PREVIOUS SURGERY. THE SURGEON REMOVED THE NAIL AND SCREWS THAT WERE PLACED DURING PRIMARY SURGERY. THE SURGEON CLEANED OUT THE NONUNION SITE, PERFORMED A RIA PROCEDURE TO OBTAIN A BONE GRAFT, PLACED A NEW NAIL AND THE BONE GRAFT AND THEN COMPRESSED THE NONUNION SITE WITH A LARGE FRAGMENT PLATE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17961728 ↗
• 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 36MM FOR IM NAILS THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17512277 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE SURGEON COMPLAINED THAT THE 5.0 LOCKING SCREWS DID NOT GET GOOD PURCHASE IN THE TIBIA.( THE SCREW "BITE" IN BONE WAS NOT GREAT).HOWEVER, THE SURGERY WAS SUCCESSFULLY COMPLETED. ADDITIONALLY AT THE THE END OF THE CASE, WE DISCUSSED TIBIAL NAIL ADVANCED AND HOW THE NEW 5.0 LOCKING SCREW HAVE BETTER PURCHASE AND LOCK INTO THE NAIL. HE SAID HE WOULD NOT USE IT BECAUSE THEY HAD SEVERAL NAILS BREAK AND POLY SLEEVES COME OUT OF THE NAILS. HE ASKED HIM WHEN THAT OCCURRED AND HE SAID DURING RESIDENCY. HE DID NOT DISPUTE HIS CLAIM, HOWEVER HE BELIEVE HE WENT TO RESIDENCY WELL BEFORE TNA CAME OUT. THERE WAS NO SURGICAL DELAY AND NO PATIENT OUTCOME. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 36 FOR IM NAILS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060295 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE SURGEON COMPLAINED THAT THE 5.0 LOCKING SCREWS DID NOT GET GOOD PURCHASE IN THE TIBIA.( THE SCREW "BITE" IN BONE WAS NOT GREAT).HOWEVER, THE SURGERY WAS SUCCESSFULLY COMPLETED. ADDITIONALLY AT THE END OF THE CASE, WE DISCUSSED TIBIAL NAIL ADVANCED AND HOW THE NEW 5.0 LOCKING SCREW HAVE BETTER PURCHASE AND LOCK INTO THE NAIL. HE SAID HE WOULD NOT USE IT BECAUSE THEY HAD SEVERAL NAILS BREAK AND POLY SLEEVES COME OUT OF THE NAILS. HE ASKED HIM WHEN THAT OCCURRED AND HE SAID DURING RESIDENCY. HE DID NOT DISPUTE HIS CLAIM, HOWEVER HE BELIEVE HE WENT TO RESIDENCY WELL BEFORE TNA CAME OUT. THERE WAS NO SURGICAL DELAY AND NO PATIENT OUTCOME. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 36 FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060148 ↗
• InjuryNov 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, A REVISION OF NAILING WAS DONE DUE TO MALREDUCTION. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 15775500 ↗
• 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: Fatigue

  MAUDE report 15093399 ↗
• InjuryMar 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 WAS UNDERWENT A REVISION OF FEMUR NAIL DUE TO ANTERIOR THIGH PAIN. THERE WAS NO SURGICAL DELAY WAS REPORTED. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 13908464 ↗
• InjuryMar 9, 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 REMOVED ONE (1) TFNA SHORT NAIL, ONE (1) TFNA SCREW, AND ONE (1) 5.0 TITANIUM LOCKING SCREW WITH T25 STARDRIVE RECESS. THE PATIENT WAS INFECTED AND THE HARDWARE HAD TO BE REMOVED. EVERYTHING WAS REMOVED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS THIS IS REPORT 3 OF 3 FOR COMPLAINT PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13713860 ↗
• 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 ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13560185 ↗
• InjuryJul 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A REVISION OF A TIBIAL SHAFT FRACTURE HYPERTROPHIC NON-UNION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS AND REVISED. ALL IMPLANTS WERE INTACT UPON REMOVAL NOTHING WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING FINE POST-OPERATIVLELY. THERE WERE NO COMORBIDITIES FOR THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS ON THE MONTH OF (B)(6) 2019. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12116469 ↗
• InjuryMay 27, 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 REVISION SURGERY DUE TO A NON-UNION OF THE LEFT TIBIAL SHAFT. THE IMPLANTS THAT WERE REMOVED WERE TITANIUM CANNULATED TIBIAL NAIL, END CAP, AND THREE TITANIUM LOCKING SCREWS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11894325 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON OCTOBER 21, 2020, PATIENT UNDERWENT PARTIAL REMOVAL OF ONE (1) TITANIUM LOCKING SCREW 36MM, ONE (1) TITANIUM LOCKING SCREW 28MM AND ONE (1) TITANIUM END CAP DUE TO MALUNION, REVISION WITH TIBIAL ROTATIONAL OSTEOTOMY. ONE (1) UNKNOWN TIBIAL NAIL AND TWO (2) UNKNOWN SCREWS WERE NOT REMOVED. THE PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Impaired Healing; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10854479 ↗
• 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 2 CORTEX SCREWS, 1 TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND, 4 TITANIUM LOCKING SCREW AND 1 TITANIUM END CAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW SELF-TAPPING 40MM (PART NUMBER 204.84, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 44MM (PART NUMBER 204.844, LOT UNKNOWN, QUANTITY 1), 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE (PART NUMBER 04.034.449S, LOT 22P4336, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART NUMBER 04.005.530, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART NUMBER 04.005.528, 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 1 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 7 OF 8 FOR (B)(4

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

  MAUDE report 10108366 ↗
• InjuryMay 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT CAME IN WITH A DISTAL FEMUR FRACTURE ON THE SAME SIDE BELOW THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE HELICAL BLADE WAS REMOVED BECAUSE IT WAS IN THE WAY OF THE PLATE. THERE WAS NO PROBLEM WITH THE IMPLANT AND NO IMPLANT FAILURE. THERE WAS PROMINENCE FROM THE NORMAL COLLAPSE THAT HAPPENED TO BE IN THE WAY. AN INTERLOCKING SCREW WAS REMOVED AS WELL. THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2016. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS WAS NORMAL. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8612195 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON AN UNKNOWN DATE IN 2012. ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF A TIBIAL NAIL, LOCKING SCREW 72MM, LOCKING SCREW 40MM, TWO (2) LOCKING SCREW 36MM, AND LOCKING SCREW 46MM DUE TO PARTIAL NON-UNION, DELAYED HEALING, INFLAMMATION AND INFECTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS SATISFACTORY. THIS REPORT IS FOR ONE (1) LOCKING SCREW 36MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 8496522 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON AN UNKNOWN DATE IN 2012. ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF A TIBIAL NAIL, LOCKING SCREW 72MM, LOCKING SCREW 40MM, TWO (2) LOCKING SCREW 36MM, AND LOCKING SCREW 46MM DUE TO PARTIAL NON-UNION, DELAYED HEALING, INFLAMMATION AND INFECTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS SATISFACTORY. THIS REPORT IS FOR ONE (1) LOCKING SCREW 36MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 8496514 ↗
• InjuryMar 26, 2019Break; Break

  UPDATE: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF THE TIBIA DIAPHYSEAL SEGMENT. THE TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND WAS REMOVED. ONE (1) TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 60MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 44MM,ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, AND ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 54MM WAS REMOVED DUE TO A NON-UNION . IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOMES WERE UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8454451 ↗