SynFrame 387.336Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034771052), received between Sep 24, 2018 and Oct 24, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE OF THE SYNFRAME RINGS WOULD NOT TIGHTEN FULLY AND SEEMS TO BE WORN. THIS REPORT INVOLVES ONE (1) SYNFRAME HOLDING RING TWO-PIECE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996857 ↗
• MalfunctionJun 9, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT A SCREW IS NOT PROPERLY TIGHTENED IN THE RING, IS TWISTED AND IS STUCK CANNOT BE REMOVED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SYNFRAME HOLDING RING Ø300 2PART CPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097644 ↗
• MalfunctionApr 10, 2020Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SYNFRAME EXTENSIONS ARE FAULTY; THE SCREWS ARE IN THE INCORRECT ORIENTATION AND THUS THE RING COULDN¿T BE ASSEMBLED. THE SURGICAL STAFF WERE ABLE TO USE BREAKABLE SYNFRAME HINGES AS EXTENDERS INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SYNFRAME HOLDING RING (PART: 387.336, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME EXTENSION (PART: 387.338, LOT: 4L53724, QUANTITY: 2) THIS REPORT IS FOR A SYNFRAME HALF RING. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9950004 ↗
• MalfunctionApr 10, 2020Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SYNFRAME EXTENSIONS ARE FAULTY; THE SCREWS ARE IN THE INCORRECT ORIENTATION AND THUS THE RING COULDN¿T BE ASSEMBLED. THE SURGICAL STAFF WERE ABLE TO USE BREAKABLE SYNFRAME HINGES AS EXTENDERS INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SYNFRAME 1/2 RING (PART: 387.337, LOT: UNKNOWN, QUANTITY: 1), SYNFRAME EXTENSION (PART: 387.338, LOT: 4L53724, QUANTITY: 2) THIS REPORT IS FOR A SYNFRAME HOLDING RING TWO-PIECE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9949986 ↗
• MalfunctionMar 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SYNFRAME SENT HAD A DAMAGED PART ON IT. THE SYNFRAME HAS A LARGE RING WHICH IS HELD TOGETHER BY SCREWS ON ITS DIAMETER. THERE IS AN ISSUE WITH THE LOCKING SCREWS THAT MEANS THE RING WAS NOT STABLE DURING USE. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SYNFRAME HOLDING RING TWO-PIECE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847747 ↗
• MalfunctionSep 24, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2018, ONE OF THE SCREWS OF THE SYNFRAME HOLDING RING TWO-PIECE WAS STRIPPED AND HARD TO TIGHTEN. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A SYNFRAME HOLDING RING TWO-PIECE. CONCOMITANT DEVICE: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7903075 ↗