NA 206.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982147226), received between Dec 18, 2018 and Nov 4, 2022 — classified as 4 injuries, 1 malfunction.

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

• MalfunctionNov 4, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW ENVELOPE WAS EMPTY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725948 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT REPORTED BLISTERS ON SURGICAL FOOT, WHICH HAS SPREAD TO OTHER PARTS OF HER BODY. PATIENT IS BEING TESTED FOR AN ALLERGIC REACTION TO THE IMPLANTS. NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)4.0 CANCELLOUS BONE SCREW FULLY THRD/14. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 15183736 ↗
• InjuryJan 2, 2020Adverse 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 A RIGHT TOTAL KNEE ARTHROPLASTY REVISION TO ADDRESS LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. IT WAS NOTED THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016. DURING THE PROCEDURE, IT WAS IDENTIFIED THAT TWO (2) SYNTHES SCREWS WERE USED ALONG THE LATERAL SIDE TO ACT AS REBARB FOR CEMENT, UPON RELEASING THE TOURNIQUET, A LARGE RUSH OF BLOOD WAS OBSERVED FROM THE POSTERIOR KNEE. THE BLEEDING WAS CONTROLLED AND THE PATIENT WAS IN STABLE CONDITION WITH NO APPARENT COMPLICATIONS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 9538531 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 8 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 28 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES

  Patient problems: No Code Available

  MAUDE report 8641442 ↗
• 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 DECEMBER 2, 2018 THAT THE DEVICES ARE 316L STAINLESS STEEL AND NOT COATED WITH POLYETHYLENE, POLYPROPYLENE GLYCOL, OR WAX. THIS REPORT IS FOR A 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/14MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 8173442 ↗