NA 212.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982151858), received between Nov 30, 2017 and Apr 21, 2022 — classified as 5 injuries, 1 malfunction.

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

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

  THIS IS REPORT 1 OF 12 FOR (B)(4). IT WAS REPORTED BY AN JOHNSON AND JOHNSON EMPLOYEE THROUGH THE LEGAL DEPARTMENT THAT ON (B)(6) 2020, THE PATIENT HAD HUMERUS OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE DUE TO FAILURE OF IMPLANTED PLATE. THEN ON (B)(6) 2020, THE PATIENT HAD FAILED FIXATION IN THE DISTAL HUMERUS LEFT UPPER EXTREMITY. ACCORDING TO THE REPORT, THE PATIENT HAD A REMOVAL OF HARDWARE IN THE HUMERUS WITH IRRIGATION WITH DEBRIDMENT FOR PERSISTENT NONUNION AND OSTEOMYELITIS. IT WAS REPORTED THAT OPERATIVE NOTED EXPLANTED FRACTURED DISTAL HUMERUS PLATE AND ALL ITS SCREWS. IT WAS REPORTED THAT DURING REVISION THERE WERE NO SIGN OF INFECTION SUCH AS PUS. THERE WERE ALSO A FINDINGS OF A NECROTIC SHAFT END AND NO GROSS EVIDENCE OF INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 30 DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 14172206 ↗
• MalfunctionJun 9, 2021Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING OSTEOTOMY PROCEDURE OF A DISTAL TIBIA, THE SURGEON CROSS INSERTED A 3.5 LOCKING OFF AXIS AND TOOK NOTICED THAT HE HAD POTENTIALLY CROSSED THREADED THE SCREW. IN THE SAME SURGERY, THE SURGEON ALSO BENT A 3.5 CORTEX SCREW THAT HE HAS USED AS A LAG SCREW ACROSS. H LEFT THE SCREWS IN AND COMPLETED THE CASE SUCCESSFULLY. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS FOR ONE (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 30. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966014 ↗
• 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 3); 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 5 OF 10 FOR (B)(4). AN ADDITIONAL DEVICE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Reaction

  MAUDE report 9861902 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: ALLERGY TESTING WILL NOT BE COMPLETED UNTIL EARLY MAY, 2019. IT IS A 4 ¿ 6 STEP PROCESS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8383744 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOW IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 6 OF 16 FOR PC-000054012.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7071290 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOWN IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 8 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7071282 ↗

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,