NA 212.119Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982151933), received between Oct 8, 2018 and Mar 7, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE WHEN APPLYING A PROXIMAL HUMERUS PLATE, THE ONE OF THE CRITICAL LOCKING SCREWS PROXIMAL IN THE PLATE WOULD NOT ENGAGE WITH THE LOCKING SCREW. ANOTHER PLATE/SCREW WAS USED WITHOUT FURTHER INCIDENT. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 45 THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499526 ↗
• 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) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM. THIS REPORT IS 5 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132514 ↗
• 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

  Patient problems: Reaction

  MAUDE report 9861866 ↗
• 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 2); 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 CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN LCP SCREW. THIS IS REPORT 3 OF 10 FOR (B)(4). AN ADDITIONA

  Patient problems: Reaction

  MAUDE report 9861847 ↗
• 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 2); 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 CORTEX SCREW SELF-TAPPING 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM (PART 212.114, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN LCP SCREW. THIS IS REPORT 2 OF 10 FOR (B)(4). AN ADDITIONA

  Patient problems: Reaction

  MAUDE report 9861828 ↗
• 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 45MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8155347 ↗
• 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 45MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8155332 ↗
• InjuryOct 8, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LOCKING SCREW APPEARED TO BE BROKEN. A FOLLOW UP X-RAY THEN REVEALED THAT THE SCREW HAD COME OFF OF THE UNKNOWN PEDIATRIC HIP PLATE. IT IS UNKNOWN IF REVISION SURGERY HAS BEEN PLANNED. CONCOMITANT DEVICE: PEDIATRIC HIP PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 3.5MM LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7942783 ↗

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,