NA 204.834Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982146359), received between Feb 24, 2018 and Apr 17, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF (B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTAL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16753049 ↗
• InjuryDec 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A TIBIAL PLATEAU OPEN REDUCTION INTERNAL FIXATION (ORIF) WHILE INSERTING A 3.5 CORTEX SCREW ON POWER, THE HEAD OF THE SCREWDRIVER SNAPPED OFF INTO THE HEAD OF THE SCREW. A MEDIAL INCISION WAS MADE, AND THE SCREW WAS BACKED OUT AND REMOVED AND REPLACED. ALL FRAGMENTS REMOVED FROM THE PATIENT. ACTION TAKEN WHEN THE EVENT OCCURRED MEDIAL INCISION TO BACK THE SCREW OUT. THERE WAS A SURGICAL DELAY OF 30 (THIRTY) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11073604 ↗
• 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 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 34MM. THIS IS REPORT 2 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491144 ↗
• 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 PERFO

  Patient problems: Unspecified Infection

  MAUDE report 8193041 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. THE PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE THE FOLLOWING VARIABLE ANGLE DISTAL HUMERUS, VARIABLE ANGLE-LCP LATERAL DISTAL HUMERUS, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) CORTEX SCREW SELF- TAPPING. DURING THE PROCEDURE, ALL HARDWARE WAS REMOVED AND WAS INTACT. THERE WAS NO COMPLICATIONS OR EXTENDED TIME NEEDED. THE FRACTURE WAS REDUCED AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATES AND UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE. THERE WERE NO X-RAYS ARE AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8128475 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TIBIAL PLATEAU PROCEDURE ON AN UNKNOWN DATE. WHILE IMPLANTING A 3.5 MM CORTEX SCREW FOR THE PROCEDURE, THE HEAD OF THE SCREW SNAPPED OFF IN THE PATIENT. THE SHAFT OF THE SCREW COULD NOT BE RECOVERED. THE SURGEON BELIEVED THAT THERE WAS NO ISSUE LEAVING THE SHAFT IN THE PATIENT. THE SURGICAL DELAY AND PATIENT OUTCOME WERE UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN TIBIAL PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548665 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEGAL DEPARTMENT REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT ON (B)(6) 2013 (APPROXIMATE DATE), PATIENT ASSISTED A FRIEND BY LOADING A MOTORCYCLE ON TO A TRAILER WHEN THE MOTORCYCLE FELL ON TO HIS LOWER RIGHT LEG. PATIENT SUSTAINED A DISTAL TIBIA AND FIBULA FRACTURE ABOVE THE RIGHT ANKLE. PATIENT UNDERWENT SURGERY ON (B)(6)2013 (APPROXIMATE DATE) TO IMMOBILIZE THE LOWER RIGHT LEG/ANKLE FOR THE HEALING PROCESS AND WAS IMPLANTED WITH SYNTHES LOCKING SMALL FRAGMENT SET WHICH CONSISTED OF PLATES AND SCREWS. IN (B)(6) 2015 PATIENT NOTICED PAIN AND SWELLING AND A CURVATURE THAT BEGAN TO DEVELOP IN HIS LOWER RIGHT LEG/ANKLE AND WENT TO THE EMERGENCY ROOM IN (B)(6) 2015 AT ONE HOSPITAL AND THEN TO ANOTHER HOSPITAL DUE TO THE PAIN AND THE DEFORMITY DEVELOPING IN HIS LOWER RIGHT LEG/ANKLE. X-RAYS TAKEN ON (B)(6) 2015 (APPROXIMATE DATE) AND AGAIN ON (B)(6) 2015 (APPROXIMATE DATE) REVEALING A CURVATURE/DEFORMITY . IT WAS NOTED THAT THE PLATE WAS BROKEN ALONG WITH MANY OF THE SCREWS AND THERE WAS A NONUNION OF THE TIBIA AND FIBULA FRACTURES. AFTER THE EMERGENCY ROOM VISIT, PATIENT WENT TO A MEDICAL CENTER FOR FURTHER EVALUATION. PATIENT WAS INFORMED ABOUT UNDERGOING REVISION SURGERY

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7295078 ↗