SynFrame 387.345Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034771113), received between Feb 6, 2020 and Sep 22, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858730 ↗
• MalfunctionAug 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE NUT ON THE SYNFRAME CONNECTING ROD IS STUCK FAST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709072 ↗
• MalfunctionApr 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 , IT WAS NOTED FOUR ITEMS FROM THE SYNFRAME SET WERE DAMAGED/LONGER WORKING. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOTED THE DEVICES WERE WORN, STRIPPED AND CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805867 ↗
• MalfunctionNov 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN USING THE SYNFRAME FRAME, A SCREW FROM A COMPONENT OF THE FRAME BROKE INTRAOPERATIVELY. THE FRAME WAS ATTACHED BY THE USER AS USUAL. ONCE THE FRAME HAD BEEN FIXED IN PLACE, IT WAS RETURNED TO THE SITUS. UNTIL SUDDENLY THE SCREW IN QUESTION BROKE. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598555 ↗
• MalfunctionNov 24, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON NOVEMBER 1, 2023, THAT THE NUT/TIGHTENING SCREW ON ITEM 387.345, SYNFRAME HOLDING ROD, IS STUCK FAST AND CANNOT BE UNDONE. THERE WAS NO INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME CONNECTING ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204564 ↗
• MalfunctionNov 7, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SYNFRAME CONNECTING ROD IN QUESTION WAS FOUND WITH A NUT THAT IS STUCK FAST AND CANNOT BE UNDONE. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNFRAME CONNECTING ROD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18086696 ↗
• MalfunctionJul 31, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A CUSTOMER ASKING IF A BROKEN INSTRUMENT IS UNDER WARRANTY. NO REMOVAL OR REVISION SURGERY NEEDED. THIS HAPPENED AFTER THE SURGERY WAS COMPLETED. IT¿S AN INSTRUMENT, NOT IMPLANT . NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME CONNECTING ROD THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430113 ↗
• MalfunctionApr 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON FEBRUARY 9, 2023, THE DISTRIBUTOR REPORTED TWO INSTRUMENTS SPREADER FORCEPS CURV & SYNFRAME CONNECT ROD F/HOLD-RINGS NOS. 38 IN THEIR POSSESSION WERE BROKEN. NO FURTHER DETAILS ON HOW THE INSTRUMENTS BROKE WERE PROVIDED. IT WAS UNKNOWN IF THERE ANY PATIENT INVOLVEMENT OR NOT. THIS REPORT IS FOR ONE (1) SYNFRAME CONNECTING ROD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839555 ↗
• MalfunctionAug 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ALL PARTS OF A SPINE KIT THAT NEED TO BE TIGHTENED OR LOCKED NEED TO BE LUBRICATED. THIS WAS NOTED DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) CASE ON (B)(6) 2020 WHERE THERE WERE DEVICE INTERACTION ISSUES. ADDITIONALLY, 2 BLUE CLAMPS HAVE BEEN TAGGED BECAUSE THEY WERE NOT GRIPPING TO THE O-RING PROPERLY. CONCOMITANT DEVICE REPORTED: UNKNOWN O-RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381156 ↗
• MalfunctionAug 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ALL PARTS OF A SPINE KIT THAT NEED TO BE TIGHTENED OR LOCKED NEED TO BE LUBRICATED. THIS WAS NOTED DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) CASE ON (B)(6) 2020 WHERE THERE WERE DEVICE INTERACTION ISSUES. ADDITIONALLY, 2 BLUE CLAMPS HAVE BEEN TAGGED BECAUSE THEY WERE NOT GRIPPING TO THE O-RING PROPERLY. CONCOMITANT DEVICE REPORTED: UNKNOWN O-RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380872 ↗
• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT A SYNFRAME CONNECTING ROD IS BROKEN. THE ISSUE WAS DISCOVERED IN CENTRAL STERILE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME CONNECTING ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10254629 ↗
• MalfunctionFeb 6, 2020Break; Break

  IT WAS REPORTED THAT DURING INSERVICE OF THE DEVICE ON (B)(6) 2020, THE SCREW OF THE SYNFRAME CONNECTING ROD WAS NOTICED TO BE BROKEN, RENDERING IT USELESS. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR A SYNFRAME CONNECTING ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9678183 ↗