NA 212.117Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982151919), received between Dec 12, 2018 and Jul 21, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWS IN QUESTION WERE REMOVED DUE TO LONGER SIZES BEING NECESSARY. THE PATIENT DID NOT EXPERIENCE A POST-OP DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15077770 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: 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 WAS EXPERIENCING UNKNOWN SYMPTOMS AND WAS DEALING WITH THIS FOR 5 YEARS. THE PATIENT WANTED THE PLATE AND SCREWS TO BE REMOVED. ON (B)(6)2015, THE PATIENT HAD A CHECK-UP DUE TO SKIN LESION THAT WAS LOCATED ON HER RIGHT UPPER ARM THAT WAS SWOLLEN, PAINFUL, AND ENLARGING, MODERATE IN SEVERITY AND HAS BEEN PRESENT FOR TWO WEEKS. THIS LESION HAS NOT BEEN TREATED IN THE PAST. ON (B)(6)2015, THE PATIENT WHO IS FOLLOWING UP FOR ABSCESS ON THE RIGHT ARM. SHE WAS TREATED WITH I&D SIMPLE OR SINGLE AND LABS WERE ORDERED. ON (B)(6)2016, THE PATIENT UNDERWENT AN ELLIPTICAL SURGICAL EXCISION WITH COMPLEX LAYERED CLOSURE DUE TO SCAR REVISION ON THE RIGHT UPPER ARM. THE FOLLOWING REPAIR WAS INDICATED TO CLOSE THE RESULTING WOUND, REDUCE ANATOMIC DISTORTION AND SCARRING, AND MINIMIZE SKIN TENSION THAT COULD LEAD TO WOUND INFECTION OR DEHISCENCE. ON (B)(6)2019, THE SCAR IS GROWING AND

  Patient problems: Reaction

  MAUDE report 9862047 ↗
• 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 LOCKING SCREW SELF-TAPPING WITH STARDRIVE(TM) RECESS 40MM. THIS IS REPORT 5 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491595 ↗
• 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 8193017 ↗
• 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 LOCKING SCREW 40MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8154881 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,