NA 204.830Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982146335), received between Oct 17, 2018 and Oct 4, 2023 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 17868982 ↗
• 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 17867823 ↗
• 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 STIFF

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17863785 ↗
• 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 17863722 ↗
• 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 17863672 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS REMOVAL OF HARDWARE DUE TO MALUNION. A PREVIOUS SURGERY WAS DONE IN (B)(6), AND PATIENTS TIBIA HEALED IN EXTREME VARUS. A CORRECTION SURGERY WAS COMPLETED FOLLOWING THE HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL WAS DUE TO EXTREME VARUS DEFORMITY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Deformity/ Disfigurement; Malunion of Bone

  MAUDE report 16251150 ↗
• 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 9 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090209 ↗
• 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) OF 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 30MM. THIS IS REPORT 17 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797853 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OCTOBER 18 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) OF 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 30MM. THIS IS REPORT 7 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12796950 ↗
• InjuryOct 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, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. ONE (1) 2.7 MM VARIABLE ANGLE LOCKING SCREW 40MM WAS FOUND BROKEN DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT THE 2.7 MM VARIABLE ANGLE LOCKING SCREW 4MM. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TOTAL 23 DEVICES. (B)(4) REPORTS 10 DEVICES, ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10620399 ↗
• InjuryOct 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, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10620095 ↗
• InjuryOct 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, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10620058 ↗
• InjuryOct 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, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10619995 ↗
• MalfunctionDec 6, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON NOVEMBER 15, 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 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9428421 ↗
• InjuryApr 8, 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 REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT PROXIMAL HUMERUS DUE TO NONUNION. THE FOLLOWING HARDWARE WAS REMOVED: ONE (1) LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE-STANDARD 3H HEAD SHAFT. ONE (1) CORTEX SCREW SELF-TAPPING 34MM. ONE (1) CORTEX SCREW SELF-TAPPING 30MM. TWO (2) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 52MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 40MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 48MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 38MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 50MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 46MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 32MM. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL HARDWARE WAS REMOVED SUCCESSFULLY AND INTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 3 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491384 ↗
• InjuryDec 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PER

  Patient problems: Unspecified Infection

  MAUDE report 8193051 ↗
• 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 OCTOBER 2, 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 30MM. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7975988 ↗