NA 201.932Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20887587028658), received between Aug 20, 2018 and Aug 7, 2023 — classified as 1 injury, 3 malfunctions.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2023Break; Break

  THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469666 ↗
• MalfunctionFeb 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE HOLDING SLEEVE OF THE INTERMAXILLARY FIXATION (IMF) SCREW DID NOT HOLD THE HEAD OF THE SCREWS WELL; WHEN THE SCREWS WERE PLACED THEY MOVE A LOT, MAKING PLACEMENT DIFFICULT. IT WAS NOTED A LOT OF FORCE WAS PLACED ON TWO (2) SELF-DRILLING INTERMAXILLARY FIXATION (IMF) SCREWS TO PLACE THEM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR AN INTERMAXILLARY FIXATION (IMF) SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377933 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT DURING A MANDIBULAR OSTEOTOMY ON AN UNKNOWN DATE, THE SELF DRILLING SCREW BROKE OFF IN PATIENT'S JAW AT THE SCREW HEAD-SHAFT INTERFACE. THE REMAINING FRAGMENT OF SCREW WAS SAID TO BE BELOW THE SURFACE AND THE SURGEON DEEMED THE BEST COURSE OF ACTION WAS TO LEAVE IT IN PLACE. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 2.0MM INTERMAXILLARY FIXATION (IMF) SCREW SELF-DRILLING 12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8178640 ↗
• InjuryAug 20, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CERCLAGE PROCEDURE ON (B)(6) 2018, THE HEAD OF AN INTERMAXILLARY FIXATION (IMF) SCREW WAS BROKEN. THE BODY OF THE IMF SCREW WAS ALREADY IN THE PATIENT'S BONE HOWEVER THE SCREW HEAD REMAINED OUTSIDE THE BONE AND WAS IMPOSSIBLE TO REMOVE. THE SCREW BODY WAS LEFT IN THE PATIENT'S BONE AND TO PREVENT THE PATIENT FROM EXPERIENCING PAIN, THE SURGEON USED THE REAMERS TO HAVE THE BROKEN SCREW BE AT THE SAME LEVEL WITH THE PATIENT'S BONE. THERE WAS A SURGICAL DELAY OF TEN TO FIFTEEN MINUTES. PATIENT OUTCOME WAS REPORTED AS NORMAL. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7798326 ↗