NA 204.826Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982146311), received between Nov 30, 2017 and Jan 28, 2025 — classified as 20 injuries, 1 malfunction.

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.

• InjuryJan 28, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024 A GRADE 2 OPEN PILON FRACTURE WITH ASSOCIATED DISTAL FIBULA FRACTURE WAS FIXATED WITH A 2.7MM/3.5MM ANTEROLATERAL DISTAL TIBIA PLATE AND 2.7, MM/ 3.5MM DISTAL FIBULA PLATE. AFTER FIXATION, 6CC OF FIBERGRAFT GPS PUTTY WAS INJECTED INTO THE BONY VOID. THE PATIENT PRESENTED ON (B)(6) 2024 WITH A MECHANICAL FAILURE OF THE CORTICAL SCREWS IN THE SUPERIOR ASPECT OF THE PLATE. NO SCREWS OR THE PLATE WERE BROKEN AND DISTAL BLOCK REMAINED INTACT, SURGEON EXPLAINED THE PATIENT WAS NON-COMPLIANT. THE SCREWS HAD BACKED OUT OF THE PLATE. ON (B)(6) 2025 THE PATIENT WAS REOPERATED ON TO CORRECT MECHANICAL FAILURE. THE SCREWS WERE REPLACED WITH 3.5MM VA LOCKING SCREW. THE VA LCP AND ANTEROLATERAL DISTAL TIBIA PLATE AND LCP DISTAL FIBULA PLATE WERE NOT AFFECTED. UPON OPENING THE INCISION, THE FIBERGRAFT WAS DRAINING FROM THE INCISION AND WAS SENT FOR CULTURE AND CAME BACK NEGATIVE. THE FRACTURE WAS RE-REDUCED AND RE-FIXATED. THERE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21251177 ↗
• InjuryJan 28, 2025Migration; Migration

  IT WAS REPORTED THAT ON DECEMBER 4, 2024 A GRADE 2 OPEN PILON FRACTURE WITH ASSOCIATED DISTAL FIBULA FRACTURE WAS FIXATED WITH A 2.7MM/3.5MM ANTEROLATERAL DISTAL TIBIA PLATE AND 2.7, MM/ 3.5MM DISTAL FIBULA PLATE. AFTER FIXATION, 6CC OF FIBERGRAFT GPS PUTTY WAS INJECTED INTO THE BONY VOID. THE PATIENT PRESENTED ON (B)(6) 2024 WITH A MECHANICAL FAILURE OF THE CORTICAL SCREWS IN THE SUPERIOR ASPECT OF THE PLATE. NO SCREWS OR THE PLATE WERE BROKEN AND DISTAL BLOCK REMAINED INTACT, SURGEON EXPLAINED THE PATIENT WAS NON-COMPLIANT. THE SCREWS HAD BACKED OUT OF THE PLATE. ON (B)(6) 2025 THE PATIENT WAS REOPERATED ON TO CORRECT MECHANICAL FAILURE. THE SCREWS WERE REPLACED WITH 3.5MM VA LOCKING SCREW. THE VA LCP AND ANTEROLATERAL DISTAL TIBIA PLATE AND LCP DISTAL FIBULA PLATE WERE NOT AFFECTED. UPON OPENING THE INCISION, THE FIBERGRAFT WAS DRAINING FROM THE INCISION AND WAS SENT FOR CULTURE AND CAME BACK NEGATIVE. THE FRACTURE WAS RE-REDUCED AND RE-FIXATED. THERE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21251108 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2022 THE PATIENT MET WITH A ROAD TRAFFIC ACCIDENT THROUGH BIKE AND SUSTAINED INJURIES, HEAD AND PELVIC FRACTURE. THE INJURIES ARE LIKE HEAD INJURY, DIFFUSE TRAUMATIC SUBARACHNOID HEMORRHAGE, LEFT ORBITAL WALL FRACTURE AND PATELLA/LEFT HIP FRACTURE. ON (B)(6) 2022 THE PATIENT UNDERWENT (1ST COMPONENT) OPEN REDUCTION & INTERNAL FIXATION WITH TENSION BOND WIRING FOR LEFT PATELLA. (2ND COMPONENT) ORIF RECON PLATE FOR ANTERIOR COLUMN LEFT ACETABULUM. (3RD COMPONENT) ORIF WITH RECON PLATE POSTERIOR COLUMN LEFT ACETABULUM. ON (B)(6) 2022 THE DISTAL FEMUR PIN APPLIED DUE TO THE SURGEON DID NOT PROPERLY USED THE C-ARM AND IGNORE THE COMPONENT LEFT PATELLA WHICH LED TO THE IMPLANT GOT FAILED DUE TO DISCREPANCY REDUCTION AND USING PINS FOR TEMPORARY SOLUTION/TREATMENT. ON (B)(6) 2022 LEFT FRONTAL BURR HOLE EVACUATION OF SUBDURAL COLLECTION & PLACEMENT OF SUBDURAL RESERVOIR. ON (B)(6) 2022 THE PATIENT UNDERWENT (2ND COMPONENT OF 1ST SURGERY) REVISION ACETABULUM WITH AO POSTERIOR PLATE. ANTERIOR QUADRILATERAL PLATE AND AO BUTTRESS PLATE (RE-DO OF 3RD ITEM OF THE 1ST SURGERY DUE TO THE FRACTURE REDUCTION GOT FAILED WITH A STIFFNESS

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17868989 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2022 THE PATIENT MET WITH A ROAD TRAFFIC ACCIDENT THROUGH BIKE AND SUSTAINED INJURIES, HEAD AND PELVIC FRACTURE. THE INJURIES ARE LIKE HEAD INJURY, DIFFUSE TRAUMATIC SUBARACHNOID HEMORRHAGE, LEFT ORBITAL WALL FRACTURE AND PATELLA/LEFT HIP FRACTURE. ON (B)(6) 2022 THE PATIENT UNDERWENT (1ST COMPONENT) OPEN REDUCTION & INTERNAL FIXATION WITH TENSION BOND WIRING FOR LEFT PATELLA. (2ND COMPONENT) ORIF RECON PLATE FOR ANTERIOR COLUMN LEFT ACETABULUM. (3RD COMPONENT) ORIF WITH RECON PLATE POSTERIOR COLUMN LEFT ACETABULUM. ON (B)(6) 2022 THE DISTAL FEMUR PIN APPLIED DUE TO THE SURGEON DID NOT PROPERLY USED THE C-ARM AND IGNORE THE COMPONENT LEFT PATELLA WHICH LED TO THE IMPLANT GOT FAILED DUE TO DISCREPANCY REDUCTION AND USING PINS FOR TEMPORARY SOLUTION/TREATMENT. ON (B)(6) 2022 LEFT FRONTAL BURR HOLE EVACUATION OF SUBDURAL COLLECTION & PLACEMENT OF SUBDURAL RESERVOIR. ON (B)(6) 2022 THE PATIENT UNDERWENT (2ND COMPONENT OF 1ST SURGERY) REVISION ACETABULUM WITH AO POSTERIOR PLATE. ANTERIOR QUADRILATERAL PLATE AND AO BUTTRESS PLATE (RE-DO OF 3RD ITEM OF THE 1ST SURGERY DUE TO THE FRACTURE REDUCTION GOT FAILED WITH A STIFFNESS

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17868988 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2022 THE PATIENT MET WITH A ROAD TRAFFIC ACCIDENT THROUGH BIKE AND SUSTAINED INJURIES, HEAD AND PELVIC FRACTURE. THE INJURIES ARE LIKE HEAD INJURY, DIFFUSE TRAUMATIC SUBARACHNOID HEMORRHAGE, LEFT ORBITAL WALL FRACTURE AND PATELLA/LEFT HIP FRACTURE. ON (B)(6) 2022 THE PATIENT UNDERWENT (1ST COMPONENT) OPEN REDUCTION & INTERNAL FIXATION WITH TENSION BOND WIRING FOR LEFT PATELLA. (2ND COMPONENT) ORIF RECON PLATE FOR ANTERIOR COLUMN LEFT ACETABULUM. (3RD COMPONENT) ORIF WITH RECON PLATE POSTERIOR COLUMN LEFT ACETABULUM. ON (B)(6) 2022 THE DISTAL FEMUR PIN APPLIED DUE TO THE SURGEON DID NOT PROPERLY USED THE C-ARM AND IGNORE THE COMPONENT LEFT PATELLA WHICH LED TO THE IMPLANT GOT FAILED DUE TO DISCREPANCY REDUCTION AND USING PINS FOR TEMPORARY SOLUTION/TREATMENT. ON (B)(6) 2022 LEFT FRONTAL BURR HOLE EVACUATION OF SUBDURAL COLLECTION & PLACEMENT OF SUBDURAL RESERVOIR. ON (B)(6) 2022 THE PATIENT UNDERWENT (2ND COMPONENT OF 1ST SURGERY) REVISION ACETABULUM WITH AO POSTERIOR PLATE. ANTERIOR QUADRILATERAL PLATE AND AO BUTTRESS PLATE (RE-DO OF 3RD ITEM OF THE 1ST SURGERY DUE TO THE FRACTURE REDUCTION GOT FAILED WITH A STIFFNESS

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17863756 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE ER BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE3.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16113690 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 10 OF 12 FOR (B)(4). IT WAS REPORTED BY AN JOHNSON AND JOHNSON EMPLOYEE THROUGH THE LEGAL DEPARTMENT THAT ON (B)(6) 2020, THE PATIENT HAD HUMERUS OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE DUE TO FAILURE OF IMPLANTED PLATE. THEN ON (B)(6) 2020, THE PATIENT HAD FAILED FIXATION IN THE DISTAL HUMERUS LEFT UPPER EXTREMITY. ACCORDING TO THE REPORT, THE PATIENT HAD A REMOVAL OF HARDWARE IN THE HUMERUS WITH IRRIGATION WITH DÉBRIDEMENT FOR PERSISTENT NONUNION AND OSTEOMYELITIS. IT WAS REPORTED THAT OPERATIVE NOTED EXPLANTED FRACTURED DISTAL HUMERUS PLATE AND ALL ITS SCREWS. IT WAS REPORTED THAT DURING REVISION THERE WERE NO SIGN OF INFECTION SUCH AS PUS. THERE WERE ALSO A FINDINGS OF A NECROTIC SHAFT END AND NO GROSS EVIDENCE OF INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 26MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

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

  MAUDE report 14172592 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 8 OF 12 FOR (B)(4). IT WAS REPORTED BY AN JOHNSON AND JOHNSON EMPLOYEE THROUGH THE LEGAL DEPARTMENT THAT ON (B)(6) 2020, THE PATIENT HAD HUMERUS OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE DUE TO FAILURE OF IMPLANTED PLATE. THEN ON (B)(6) 2020, THE PATIENT HAD FAILED FIXATION IN THE DISTAL HUMERUS LEFT UPPER EXTREMITY. ACCORDING TO THE REPORT, THE PATIENT HAD A REMOVAL OF HARDWARE IN THE HUMERUS WITH IRRIGATION WITH DÉBRIDEMENT FOR PERSISTENT NONUNION AND OSTEOMYELITIS. IT WAS REPORTED THAT OPERATIVE NOTED EXPLANTED FRACTURED DISTAL HUMERUS PLATE AND ALL ITS SCREWS. IT WAS REPORTED THAT DURING REVISION THERE WERE NO SIGN OF INFECTION SUCH AS PUS. THERE WERE ALSO A FINDINGS OF A NECROTIC SHAFT END AND NO GROSS EVIDENCE OF INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 26MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

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

  MAUDE report 14172520 ↗
• InjuryNov 11, 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 SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 5 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12796855 ↗
• InjuryOct 15, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WHEN THE SURGEON WAS FIXING A TIBIA AND WAS DRILLING FOR A 3.5 CORTEX SCREW, THE DRILL BIT BROKE OFF AND A PORTION REMAINED IN THE PATIENT'S BONE. THE SURGEON THEN PUT THE CORTEX SCREW IN AND TRIED TO REMOVE THE CORTEX SCREW AND HAD DIFFICULTIES BACKING IT OUT USING AN UNKNOWN SCREWDRIVER, SO THE SURGEON DRILLED OVER THE OPPOSITE END OF THE CORTEX SCREW AND A PORTION OF IT BROKE. THERE WERE FRAGMENTS BUT THE SCREW FRAGMENTS WERE REMOVED AND ALL OF IT CAME OUT. THERE WAS A SURGICAL DELAY OF FIVE TO TEN (5-10) MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10686387 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT FELL RESULTING IN A DISPLACED RIGHT PROXIMAL HUMERUS FRACTURE. ON (B)(6) 2009, THE PATIENT UNDERWENT AN OPEN TREATMENT OF RIGHT PROXIMAL HUMERUS FRACTURE WITH TUBEROSITY REPAIR. PLATE AND SCREWS WERE IMPLANTED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A REACTION AT THE SURGICAL SITE FOR FIVE (5) YEARS. THE PATIENT WANTS THE DEVICES REMOVED. AT THIS POINT NO REVISION PROCEDURE HAS BEEN REPORTED. CONCOMITANT DEVICES: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM (PART 241.903, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM (PART 212.119, LOT UNKNOWN, QUANTITY 3); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM (PART 212.111, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM (PART 212.117, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 26MM (PART 204.826, LOT UNKNOWN, QUANTITY 2); 3.5MM CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN LCP SCREW. THIS IS REPORT 9 OF 10 FOR (B)(4). AN ADDITIONA

  Patient problems: Reaction

  MAUDE report 9862307 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT FELL RESULTING IN A DISPLACED RIGHT PROXIMAL HUMERUS FRACTURE. ON (B)(6) 2009, THE PATIENT UNDERWENT AN OPEN TREATMENT OF RIGHT PROXIMAL HUMERUS FRACTURE WITH TUBEROSITY REPAIR. PLATE AND SCREWS WERE IMPLANTED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A REACTION AT THE SURGICAL SITE FOR FIVE (5) YEARS. THE PATIENT WANTS THE DEVICES REMOVED. AT THIS POINT NO REVISION PROCEDURE HAS BEEN REPORTED. CONCOMITANT DEVICES: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM (PART 241.903, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM (PART 212.119, LOT UNKNOWN, QUANTITY 3); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM (PART 212.111, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM (PART 212.117, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 26MM (PART 204.826, LOT UNKNOWN, QUANTITY 2); 3.5MM CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN LCP SCREW. THIS IS REPORT 8 OF 10 FOR (B)(4). AN ADDITIONA

  Patient problems: Reaction

  MAUDE report 9862276 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT FELL RESULTING IN A DISPLACED RIGHT PROXIMAL HUMERUS FRACTURE. ON (B)(6) 2009, THE PATIENT UNDERWENT AN OPEN TREATMENT OF RIGHT PROXIMAL HUMERUS FRACTURE WITH TUBEROSITY REPAIR. PLATE AND SCREWS WERE IMPLANTED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A REACTION AT THE SURGICAL SITE FOR FIVE (5) YEARS. THE PATIENT WANTS THE DEVICES REMOVED. AT THIS POINT NO REVISION PROCEDURE HAS BEEN REPORTED. CONCOMITANT DEVICES: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM (PART 241.903, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM (PART 212.119, LOT UNKNOWN, QUANTITY 3); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM (PART 212.111, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM (PART 212.117, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 26MM (PART 204.826, LOT UNKNOWN, QUANTITY 2); 3.5MM CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN LCP SCREW. THIS IS REPORT 7 OF 10 FOR (B)(4). AN ADDITIONA

  Patient problems: Reaction

  MAUDE report 9862251 ↗
• InjuryJan 30, 2020Adverse 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 AN EMERGENT INCISION AND DRAINAGE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT TIBIA DUE TO OSTEOMYELITIS AND INFECTION. ON AN UNKNOWN DATE THE PATIENT FELL WITH HER LEG WENT BEHIND HER, FRACTURING HER TIBIA. SHE ALSO HAD AN OPEN DEHISCENCE OF HER SURGICAL WOUND ON THE KNEE. DUE TO THE BEND OF THE KNEE AND THE SPLIT OF THE SKIN, SHE HAS BEEN BLEEDING AND HAS AN OPENING ON HER KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN TREATMENT OF TIBIAL SHAFT FRACTURE ON THE RIGHT SIDE WITH AN INTERNAL FIXATION WITH PLATE; A SECONDARY CLOSURE OF THE SURGICAL WOUND DEHISCENCE, AND AN EXTENSIVE AND COMPLICATED 8CM AND ARTHROTOMY KNEE WITH EXPLORATION AND DRAINAGE OF THE RIGHT KNEE, WHERE THE KNEE REPLACEMENT IS LOCATED.. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 7 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9649573 ↗
• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: No Code Available; Pain

  MAUDE report 8686932 ↗
• MalfunctionApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HUMERUS FRACTURE PROCEDURE. DURING THE PROCEDURE, THE DOCTOR TRIED TO USE A THIRD BARREL PLATE AND COULD NOT BECAUSE ONE (1) CORTEX SCREW, ONE (1) CANCELLOUS SCREW AND ONE (1) LOCKING SCREW WERE NOT THREADING ON THE PLATE. THEY MENTIONED TO CHANGED THE PLATE, BUT THE DOCTOR FURIOUSLY TOOK THE PLATE AND WENT TO TEST IT, BUT THE PLATE WAS NOT THE PROBLEM. THE PROBLEM WAS WITH THE SCREWS THAT HAD THE THREADED DUSTED. THE THIRD BARREL PLATE WAS NOT PLACED IN THE PATIENT BECAUSE THE PATIENT'S BONE WAS VERY POROUS. THE DOCTOR PLACE THE PHILOS PLATE SINCE IT WAS SUFFICIENT TO REDUCE THE FRACTURE. THERE WAS A THIRTY (30) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT INJURED AND WAS DOING VERY WELL. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527123 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HUMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245191 ↗
• InjuryDec 12, 2018Break; Break

  IT WAS REPORTED A CANCER PATIENT HAD A SECTION OF THE TIBIA WITH TUMOR REMOVED. A FRESH FROZEN ALLOGRAFT WAS IMPLANTED ALONG WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) MEDIAL PROXIMAL TIBIA PLATE TEN (10) SCREWS ON (B)(6) 2018. ON UNKNOWN DATE IT WAS DETERMINED PATIENT DEVELOPED A NON-UNION DUE TO THE BREAKAGE OF FIVE (5) OF THE SCREWS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018. ALL SCREWS WERE FULLY REMOVED. PATIENT WAS REVISED TO A LARGE FRAGMENT 12-HOLE PLATE AND EIGHT (8) SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICES: 3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE (PART 239.965, LOT 5383454, QUANTITY 1). 3.5MM LOCKING SCREW 18MM (PART 212.105, LOT UNKNOWN, QUANTITY 1). 3.5MM LOCKING SCREW 20MM (PART 212.106, LOT UNKNOWN, QUANTITY 1). 3.5MM CORTEX SCREW 22MM (PART 204.822, LOT UNKNOWN, QUANTITY 1). 3.5MM CORTEX SCREW 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1). 3.5MM CORTEX SCREW 26MM (PART 204.826, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW 26MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8154824 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6), 2017 DUE TO A REFRACTURED ANKLE. THE PATIENT ORIGINALLY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ANKLE AND WAS IMPLANTED WITH A CANCELLOUS BONE SCREW, 3 CORTEX SCREWS, AND A TUBULAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2017. HOWEVER, SOMETIME LAST WEEK, THE PATIENT TRIPPED ON A CURB AND REFRACTURED HIS LEFT ANKLE. THE RESULTS OF THE HARDWARE REMOVAL SURGERY WERE SUCCESSFUL, THE PATIENT WAS REPORTED TO BE IN EXCELLENT CONDITION. ALL THE ORIGINALLY IMPLANTED HARDWARE WAS REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY. ALL AVAILABLE INFORMATION WAS RECEIVED FROM THE SALES CONSULTANT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7110040 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6), 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOW IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 16 OF 16 FOR PC-000054012.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7071291 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOWN IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 9 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7070867 ↗