NA 204.824Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982146304), received between Jul 9, 2018 and Oct 3, 2023 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• 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 17863660 ↗
• InjuryMar 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A REVISION OF A TIBIA WHERE IT DIDN¿T HEAL INITIALLY. THE SURGEON REMOVED A DISTAL TIBIA PLATE FROM A PREVIOUS SURGERY, AND THEN USED A TIBIAL NAIL FOR FIXATION. WHEN THE SURGEON WAS REMOVING THE HARDWARE, IT WAS FOUND THAT THREE CORTEX SCREWS HAD BROKEN FROM THE PREVIOUS SURGERY. THE SCREW REMOVAL SET WAS USED, AND THE REMOVAL WAS SUCCESSFULLY COMPLETED AND THE TIBIAL NAIL INSERTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 24MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16658949 ↗
• InjuryMar 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A REVISION OF A TIBIA WHERE IT DIDN¿T HEAL INITIALLY. THE SURGEON REMOVED A DISTAL TIBIA PLATE FROM A PREVIOUS SURGERY, AND THEN USED A TIBIAL NAIL FOR FIXATION. WHEN THE SURGEON WAS REMOVING THE HARDWARE, IT WAS FOUND THAT THREE CORTEX SCREWS HAD BROKEN FROM THE PREVIOUS SURGERY. THE SCREW REMOVAL SET WAS USED, AND THE REMOVAL WAS SUCCESSFULLY COMPLETED AND THE TIBIAL NAIL INSERTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 24MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16657960 ↗
• InjuryMar 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A REVISION OF A TIBIA WHERE IT DIDN¿T HEAL INITIALLY. THE SURGEON REMOVED A DISTAL TIBIA PLATE FROM A PREVIOUS SURGERY, AND THEN USED A TIBIAL NAIL FOR FIXATION. WHEN THE SURGEON WAS REMOVING THE HARDWARE, IT WAS FOUND THAT THREE CORTEX SCREWS HAD BROKEN FROM THE PREVIOUS SURGERY. THE SCREW REMOVAL SET WAS USED, AND THE REMOVAL WAS SUCCESSFULLY COMPLETED AND THE TIBIAL NAIL INSERTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 24MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16657959 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 7 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090327 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 8 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090248 ↗
• InjuryJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, REVISION ORIF PROCEDURE WAS PERFORMED OF LEFT DISTAL HUMERUS DUE TO NON-UNION PRESENCE FROM BROKEN HARDWARE. THE SURGEON PERFORMED OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON THE PATIENT'S LEFT DISTAL HUMERUS INITIALLY IN (B)(6) 2021. TWO (2) BROKEN 3.5MM CORTEX SCREWS FROM THE PREVIOUSLY IMPLANTED SYNTHES MEDIAL DISTAL HUMERUS PLATE WERE DISCOVERED. HE THEN INSERTED TWO 3.5 LOCKING SCREWS IN REPLACEMENT OF THE BROKEN SCREWS. BONE GRAFT WAS IMPLANTED AS WELL. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 24MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13190914 ↗
• InjuryJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, REVISION ORIF PROCEDURE WAS PERFORMED OF LEFT DISTAL HUMERUS DUE TO NON-UNION PRESENCE FROM BROKEN HARDWARE. THE SURGEON PERFORMED OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON THE PATIENT'S LEFT DISTAL HUMERUS INITIALLY IN (B)(6) 2021. TWO (2) BROKEN 3.5MM CORTEX SCREWS FROM THE PREVIOUSLY IMPLANTED SYNTHES MEDIAL DISTAL HUMERUS PLATE WERE DISCOVERED. HE THEN INSERTED TWO 3.5 LOCKING SCREWS IN REPLACEMENT OF THE BROKEN SCREWS. BONE GRAFT WAS IMPLANTED AS WELL. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 24MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13190913 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION AND 1 BROKEN 60MM LENGTH VA LOCKING SCREW. ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, SEVEN (7) VA LOCKING SCREWS AND ONE (1) CORTEX SCREW AND ONE (1) VA LCP DISTAL HUMERUS PLATE WERE SUCCESSFULLY EXPLANTED. THERE WAS A FRAGMENT OF THE SHAFT AND THE SCREWHEAD BUT IT WAS REMOVED EASILY WITHOUT ADDED TIME. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

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

  MAUDE report 10755379 ↗
• MalfunctionMay 1, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY TOOK A PICTURE OF THE IMPLANTS SHIPPED TO SHOW THE ORDER CONFIRMATION, HOWEVER, THE IMPLANTS WERE NOT INSIDE THE BAG AND THE BAG WAS NOT DAMAGED. THE FACILITY PLACED A STANDARD ORDER AND SIX (6) ITEMS WERE SHIPPED WITH A QUANTITY OF ONE (1) ON EACH ITEM AND NONE OF THOSE ITEMS WERE IN THE BAG. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10019173 ↗
• 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 3); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN CORTEX SCREW. THIS IS REPORT 10 OF 10 FOR (B)(4). AN ADDITIONAL DEVICE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Reaction

  MAUDE report 9862327 ↗
• MalfunctionDec 6, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE RECEIVED ENVELOPE WAS EMPTY. IT WAS MENTIONED THAT THERE WAS NOTHING IN THE ENVELOPE AND WAS SUPPOSED TO RECEIVE FIVE (5) ITEMS. THERE IS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9428512 ↗
• 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 "HEMERUS" 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 WE

  Patient problems: Pain

  MAUDE report 8245159 ↗
• InjuryOct 18, 2018Adverse 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 PROCEDURE DUE TO PAIN ON (B)(6) 2018. HARDWARE REMOVED DURING THE PROCEDURE INVOLVES ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO PAIN. ADDITIONAL PRODUCTS INVOLVED ARE ADDRESSED IN (B)(4). THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREWS IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7978644 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN. THERE WERE (1) LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE WERE REMOVED. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL SIX DEVICES THIS COMPLAINT INVOLVES TEN 10 OF THE 16 DEVICES. THIS COMPLAINT IS FOR ONE 3.5MM CORTEX SCREW SELF-TAPPING 24MM. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7975981 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NONUNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, SIX (6) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4) AND SEVEN (7) ADDITIONAL DEVICE ARE CAPTURED UNDER (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 3.5 MM CORTEX SCREW SELF-TAPPING 28 MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7802813 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NONUNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, SIX (6) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4) AND SEVEN (7) ADDITIONAL DEVICE ARE CAPTURED UNDER (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7802809 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NONUNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, SIX (6) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4) AND SEVEN (7) ADDITIONAL DEVICE ARE CAPTURED UNDER (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 3.5 MM CORTEX SCREW SELF-TAPPING 28 MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7802794 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NON UNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, EIGHT (8) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7799696 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NON UNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, EIGHT (8) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7799684 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY OF THE OLECRANON ON (B)(6) 2018 TO FIX THE HUMERUS. THE OSTEOTOMY WAS REPAIRED WITH AN OLECRANON PLATE, 2 CORTEX SCREWS, AND 4 VARIABLE ANGLE (VA) LOCKING SCREWS. ON (B)(6) 2018 THE PATIENT HAD A REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO NON-UNION. IT WAS NOTED THAT THE PROXIMAL OLECRANON DID NOT HEAL AND THE PIECE OF BONE CAME OUT OF THE SCREW PLATE CONSTRUCT, AND PATIENT ALSO EXPERIENCED MALUNION AND DECREASED RANGE OF MOTION. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS' PROXIMAL OLECRANON WAS REMOVED AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7671410 ↗