NA 212.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982151797), received between Nov 30, 2017 and Nov 11, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. 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.

• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 18. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779076 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1)3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 18. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779050 ↗
• MalfunctionDec 17, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, AN ORDER HAD A RIPPED ON THE SIDE FROM THE ACTUAL RIP OPENING WHEN IT ARRIVED FROM COLORADO AND IT WAS EMPTY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 18. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026691 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 24MM (PART NUMBER 201.374.97, LOT UNKNOWN, QUANTITY 1), 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/34MM (PART NUMBER 02.118.534, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 2), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM (PART NUMBER 02.211.022, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10444157 ↗
• 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 8193015 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD SYMPTOMS OF SWELLING, ITCHING AND A RASH IMMEDIATELY FOLLOWING AN UNKNOWN ORTHOPEDIC PROCEDURE. THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, A CANCELLOUS BONE SCREW AND A SELF-TAPPING LOCKING SCREW DUE TO A FRACTURE. THE PATIENT IS INQUIRING IF THE IMPLANTS ARE COATED WITH "POLYETHYLENE, POLYPROPYLENE GLYCOL, OR WAX", TO WHICH THEY ARE ALLERGIC. PATIENT HAS A HISTORY OF A PRIOR UNKNOWN SURGERY INVOLVING LEVELS C4, C5, C6 AND SUFFERED AN ALLERGIC REACTION FROM AN UNKNOWN METAL OBJECT PLACED ON THE CHEST. THE PATIENT CONSULTED THE DOCTOR ON (B)(6) 2018 WITH A PERSISTENT ANKLE RASH. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND CONFIRMED THAT THE FRACTURE WAS HEALING WELL. IT WAS CONFIRMED BY ENGINEERING ON (B)(6) 2018 THAT THE DEVICES ARE 316L STAINLESS STEEL AND NOT COATED WITH POLYETHYLENE, POLYPROPYLENE GLYCOL, OR WAX. THIS REPORT IS FOR A 3.5MM LOCKING SCREW 18MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 8173343 ↗
• 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 1 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7070626 ↗

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,