NA 214.830Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982154644), received between Apr 6, 2018 and Jul 3, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Break” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17246894 ↗
• InjuryJan 7, 2021Adverse 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 HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 5 OF 8 FOR (B)(4). ADDITIONAL DEVICE ARE CAPTURED UNDER RELATED (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11135803 ↗
• InjuryJan 7, 2021Adverse 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 HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES 16 DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132520 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NON UNION DUE TO UNSPECIFIED CAUSE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020 OF A FIVE (5) BROKEN 4.5MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE, AND SIX (6) CANNULATED VA LOCKING SCREW. WE OPERATED TO A NON-UNION AND PLACED A NEW UNKNOWN PLATE AND A UNKNOWN NAIL. ALL BROKEN IMPLANT FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT (PART# 02.124.417; LOT# :8915402; QUANTITY: 1), 5.0MM CANNULATED VA LOCKING SCREW/85MM (PART# 02.231.685 ; LOT# UNKNOWN; QUANTITY: 6). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10711868 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NON UNION DUE TO UNSPECIFIED CAUSE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020 OF A FIVE (5) BROKEN 4.5MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE, AND SIX (6) CANNULATED VA LOCKING SCREW. WE OPERATED TO A NON-UNION AND PLACED A NEW UNKNOWN PLATE AND A UNKNOWN NAIL. ALL BROKEN IMPLANT FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT (PART# 02.124.417; LOT# :8915402; QUANTITY: 1). 5.0MM CANNULATED VA LOCKING SCREW/85MM (PART# 02.231.685 ; LOT# UNKNOWN; QUANTITY: 6). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10711860 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NON UNION DUE TO UNSPECIFIED CAUSE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020 OF A FIVE (5) BROKEN 4.5MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE, AND SIX (6) CANNULATED VA LOCKING SCREW. WE OPERATED TO A NON-UNION AND PLACED A NEW UNKNOWN PLATE AND A UNKNOWN NAIL. ALL BROKEN IMPLANT FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT (PART# 02.124.417; LOT# :8915402; QUANTITY: 1), 5.0MM CANNULATED VA LOCKING SCREW/85MM (PART# 02.231.685 ; LOT# UNKNOWN; QUANTITY: 6), THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10711855 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NON UNION DUE TO UNSPECIFIED CAUSE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020 OF A FIVE (5) BROKEN 4.5MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE, AND SIX (6) CANNULATED VA LOCKING SCREW. WE OPERATED TO A NON-UNION AND PLACED A NEW UNKNOWN PLATE AND A UNKNOWN NAIL. ALL BROKEN IMPLANT FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT (PART# 02.124.417; LOT# :8915402; QUANTITY: 1). 5.0MM CANNULATED VA LOCKING SCREW/85MM (PART# 02.231.685 ; LOT# UNKNOWN; QUANTITY: 6). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10711849 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NON UNION DUE TO UNSPECIFIED CAUSE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020 OF A FIVE (5) BROKEN 4.5MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE, AND SIX (6) CANNULATED VA LOCKING SCREW. WE OPERATED TO A NON-UNION AND PLACED A NEW UNKNOWN PLATE AND A UNKNOWN NAIL. ALL BROKEN IMPLANT FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT (PART# 02.124.417; LOT# :8915402; QUANTITY: 1), 5.0MM CANNULATED VA LOCKING SCREW/85MM (PART# 02.231.685 ; LOT# UNKNOWN; QUANTITY: 6). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10711840 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643246 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7487557 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7487547 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7487544 ↗
• InjuryApr 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON UNKNOWN DATE FOR TREATMENT OF A HUMERAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 4.5MM NARROW (LCP)LOCKING COMPRESSION 9 HOLE/170MM PLATE AND FOUR (4) 4.5MM CORTEX SELF TAPPING 30MM SCREWS. ON AN UNKNOWN DATE POST-OPERATIVELY, PATIENT PRESENTED WITH A NON-UNION. ON (B)(6) 2018, SURGEON REMOVED IMPLANTS AND REVISED THE PATIENT TO 8-HOLE PLATE AND SCREWS. AT THE BEGINNING OF THE PROCEDURE, ONE (1) OF THE 4.5MM SCREWS WAS REPORTED AS BROKEN. THE DISTAL SHAFT PORTION OF THIS 4.5MM CORTEX SCREW WAS LEFT IN THE PATIENT¿S HUMERAL BONE. SURGEON CHOSE NOT TO RETRIEVE THE BROKEN SCREW SHAFT PORTION. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5-10-MINUTE TIME DELAY DUE TO THE BROKEN SHAFT TIP. PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICE REPORT: [UNKNOWN STRYKER HAND DRILL] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). (B)(4) IS FOR 4.5MM CORTEX SCREW BREAKING POST-IMPLANT AND (B)(4) WAS OPENED FOR THE TIP OF THE RIA BREAKING INTRAOPERATIVELY. THIS COMPLAINT IS FOR ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 7403788 ↗