SynFrame 387.347Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10705034771137), received between Dec 12, 2016 and Jun 6, 2025 — classified as 131 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (35 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. 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 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ALIF SURGERY ON (B)(6) 2025. THE SURGEON WAS USING THE SYNFRAME RETRACTOR, AND ALL THE CLAMPS THAT ATTACH THE BLADES HOLDERS TO THE RING WERE FAULTY AND KEPT SLIPPING. ALL ARE WORN ON THE BOTTOM LIP. THE CASE WAS ABLE TO BE COMPLETED WITH THE HOLDERS, HOWEVER THEY NEED TO BE REPLACED. THERE WAS A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158988 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ALIF SURGERY ON (B)(6) 2025. THE SURGEON WAS USING THE SYNFRAME RETRACTOR, AND ALL THE CLAMPS THAT ATTACH THE BLADES HOLDERS TO THE RING WERE FAULTY AND KEPT SLIPPING. ALL ARE WORN ON THE BOTTOM LIP. THE CASE WAS ABLE TO BE COMPLETED WITH THE HOLDERS; HOWEVER, THEY NEED TO BE REPLACED. THERE WAS A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158986 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ALIF SURGERY ON (B)(6) 2025. THE SURGEON WAS USING THE SYNFRAME RETRACTOR, AND ALL THE CLAMPS THAT ATTACH THE BLADES HOLDERS TO THE RING WERE FAULTY AND KEPT SLIPPING. ALL ARE WORN ON THE BOTTOM LIP. THE CASE WAS ABLE TO BE COMPLETED WITH THE HOLDERS, HOWEVER THEY NEED TO BE REPLACED. THERE WAS A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158985 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ALIF SURGERY ON (B)(6) 2025. THE SURGEON WAS USING THE SYNFRAME RETRACTOR, AND ALL THE CLAMPS THAT ATTACH THE BLADES HOLDERS TO THE RING WERE FAULTY AND KEPT SLIPPING. ALL ARE WORN ON THE BOTTOM LIP. THE CASE WAS ABLE TO BE COMPLETED WITH THE HOLDERS; HOWEVER THEY NEED TO BE REPLACED. THERE WAS A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158984 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ALIF SURGERY ON MAY 13, 2025. THE SURGEON WAS USING THE SYNFRAME RETRACTOR, AND ALL THE CLAMPS THAT ATTACH THE BLADES HOLDERS TO THE RING WERE FAULTY AND KEPT SLIPPING. ALL ARE WORN ON THE BOTTOM LIP. THE CASE WAS ABLE TO BE COMPLETED WITH THE HOLDERS, HOWEVER THEY NEED TO BE REPLACED. THERE WAS A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158983 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ALIF SURGERY ON (B)(6) 2025. THE SURGEON WAS USING THE SYNFRAME RETRACTOR, AND ALL THE CLAMPS THAT ATTACH THE BLADES HOLDERS TO THE RING WERE FAULTY AND KEPT SLIPPING. ALL ARE WORN ON THE BOTTOM LIP. THE CASE WAS ABLE TO BE COMPLETED WITH THE HOLDERS, HOWEVER THEY NEED TO BE REPLACED. THERE WAS A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158982 ↗
• MalfunctionSep 5, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TEAM IS HAVING AN ISSUE WITH THE SYNFRAME CLAMPS WHERE THE CLAMPS ARE LOSING THEIR GRIP STRENGTH ON THE FRAME. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SYNFRAME RING CLAMP FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20144427 ↗
• MalfunctionSep 5, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TEAM IS HAVING AN ISSUE WITH THE SYNFRAME CLAMPS WHERE THE CLAMPS ARE LOSING THEIR GRIP STRENGTH ON THE FRAME. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SYNFRAME RING CLAMP FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20144401 ↗
• MalfunctionSep 5, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TEAM IS HAVING AN ISSUE WITH THE SYNFRAME CLAMPS WHERE THE CLAMPS ARE LOSING THEIR GRIP STRENGTH ON THE FRAME. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SYNFRAME RING CLAMP FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20144358 ↗
• MalfunctionSep 5, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TEAM IS HAVING AN ISSUE WITH THE SYNFRAME CLAMPS WHERE THE CLAMPS ARE LOSING THEIR GRIP STRENGTH ON THE FRAME. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SYNFRAME RING CLAMP FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20144271 ↗
• MalfunctionSep 5, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TEAM IS HAVING AN ISSUE WITH THE SYNFRAME CLAMPS WHERE THE CLAMPS ARE LOSING THEIR GRIP STRENGTH ON THE FRAME. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SYNFRAME RING CLAMP FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20144067 ↗
• MalfunctionSep 5, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TEAM IS HAVING AN ISSUE WITH THE SYNFRAME CLAMPS WHERE THE CLAMPS ARE LOSING THEIR GRIP STRENGTH ON THE FRAME. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SYNFRAME RING CLAMP FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20144028 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6), 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP THIS IS REPORT 8 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608573 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JANUARY 15, 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP. THIS IS REPORT 6 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608560 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6), 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP THIS IS REPORT 7 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608559 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6), 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP THIS IS REPORT 5 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608558 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP. THIS IS REPORT 4 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608555 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP. THIS IS REPORT 3 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608551 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP. THIS IS REPORT 2 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608540 ↗
• MalfunctionJan 30, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A SURGEON PERFORMED AN ALIF PROCEDURE. SYNFRAME RING CLAMPS WERE PART OF THE SYNFRAME THAT HOLD THE RETRACTOR BLADES. THE RING CLAMPS WERE SLIPPING AFTER TIGHTENING DOWN THE RETRACTOR BLADES IN SITU UNDER PRESSURE. WE DO NOT TIME THE SURGICAL CASES; THE AVERAGE TIME FOR AN ALIF IS 60 MINUTES, AND THE XASE TOOK 60 MINUTES. THE SURGEON HAD TO READJUST THE RETRACTOR BLADES INVOLVING THE RING CLAMPS, AND HAN-HELD RETRACTION WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WEREN'T ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. THIS REPORT IS FOR ONE (1)SYNFRAME RING CLAMP. THIS IS REPORT 1 OF 8 (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608538 ↗
• MalfunctionSep 11, 2023Compatibility Problem; Compatibility Problem

  THE PATIENT WAS REPORTED TO BE RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719405 ↗
• MalfunctionSep 11, 2023Compatibility Problem; Compatibility Problem

  THE PATIENT WAS REPORTED TO BE RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719373 ↗
• MalfunctionJul 25, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A CASE THE TWO INSTRUMENTS WOULD NOT TIGHTEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH GOOD OUTCOME. THIS REPORT INVOLVES ONE (1) SYNFRAME RING CLAMP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390484 ↗
• MalfunctionJul 25, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(4)2023, DURING A CASE THE TWO INSTRUMENTS WOULD NOT TIGHTEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH GOOD OUTCOME. THIS REPORT INVOLVES ONE (1) SYNFRAME RING CLAMP. THIS IS REPORT 1 OF 2 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390440 ↗
• MalfunctionJan 31, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM NORWAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE LOCKING BUTTON ON THE SYNFRAME COULD BE PUSHED FROM SIDE TO SIDE, BUT THE TOOTH WHEELS COULD NOT BE MOVED SO THAT THE POSITION OF THE WOUND HOOKS COULD FASTEN ON. A SIMILAR PRODUCT WAS USED INSTEAD. PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS FOR A SYNFRAME RING CLAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274150 ↗