SynFrame 387.337Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705034771069), received between Aug 4, 2017 and Apr 27, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (15 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE SYNFRAME HALF-RING WAS ALREADY BROKEN BEFORE IT COULD BE USED FOR THE OPERATING ROOM ON (B)(6) 2026. WITH SOME INGENUITY AND IMPROVISATION, THE OPERATING ROOM WAS ABLE TO PROCEED AS PLANNED AND HAD NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004104 ↗
• MalfunctionJun 20, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, ITEM THE SYNFRAME RETRACTOR HOLDER TIGHTENING NUT WAS SEIZED. THE SYNFRAME HALF RING TIGHTENING NUT WAS STRIPPED AND NO LONGER HOLDING THE TWO HALF RINGS TOGETHER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302226 ↗
• MalfunctionMay 7, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT THE SCREW ON THE PART WOULD NOT TURN WHEN LOOSENING THE RING AFTER SURGERY. THE SCREWDRIVER WENT AROUND INSIDE THE RECESS. BUT DID NOT GET ENOUGH GRIP TO GRAB THE SCREW AND UNSCREW IT. USED SOME TIME TO GET THE RING APART FROM EACH OTHER DUE TO NOT GETTING THE SCREW LOOSE AGAIN. POSSIBLE FATIGUE IN THE SCREW RECESS. THE PRODUCT IS FAIRLY NEW PURCHASED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979919 ↗
• MalfunctionJan 9, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE NURSE WAS SETTING UP THE SYNFRAME AND NOTICED THAT TWO (2) SYNFRAME RINGS HAD STRIPPED SCREWS, MAKING IT DIFFICULT TO ASSEMBLE TO SYNFRAME RING. ALSO, THE SURGEON BROKE THE ROD GUIDE FOR THE SYNFRAME HOMAN BLADE. FRAGMENTS THAT WERE GENERATED WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113514 ↗
• MalfunctionJan 9, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE NURSE WAS SETTING UP THE SYNFRAME AND NOTICED THAT TWO (2) SYNFRAME RINGS HAD STRIPPED SCREWS, MAKING IT DIFFICULT TO ASSEMBLE TO SYNFRAME RING. ALSO, THE SURGEON BROKE THE ROD GUIDE FOR THE SYNFRAME HOMAN BLADE. FRAGMENTS THAT WERE GENERATED WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113446 ↗
• MalfunctionSep 10, 2024Compatibility Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Compatibility Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON (B)(6) 2024, IT WAS IDENTIFIED THAT THERE WAS BURRING IN A SCREW HEAD; SCREW WAS NOT ABLE TO BE UNSCREWED FROM EQUIPMENT. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR A SYNFRAME HALF RING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183636 ↗
• MalfunctionJun 10, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT A NURSE WAS HAVING ISSUES ASSEMBLING A SYN-FRAME RING. IT WAS REPORTED THAT THE SCREWS ARE STRIPPED. THE NURSE REQUESTED ANOTHER SET IN ORDER TO PROCEED FOR THE SURGERY. THIS EVENT OCCURRED PRE-OP, AND THE PATIENT WAS NOT IMPACTED. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506657 ↗
• MalfunctionJun 10, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT A NURSE WAS HAVING ISSUES ASSEMBLING A SYN-FRAME RING. IT WAS REPORTED THAT THE SCREWS ARE STRIPPED. THE NURSE REQUESTED ANOTHER SET IN ORDER TO PROCEED FOR THE SURGERY. THIS EVENT OCCURRED PRE-OP, AND THE PATIENT WAS NOT IMPACTED. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505948 ↗
• MalfunctionFeb 20, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON DECEMBER 10, 2023, THE SYNFRAME HALF RING HAD A SCREW THAT WAS STRIPPED AND NO LONGER HOLDS THE TWO HALVES TOGETHER. THE DAMAGED PRODUCT WAS REPORTED AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOTED THAT UPON THE PRODUCT RETURN, THERE WERE TWO INVOLVED SYNFRAME HALF RINGS. THIS REPORT INVOLVES ONE SYNFRAME HALF RING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740035 ↗
• MalfunctionFeb 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON FEBRUARY 5, 2024, THE SCREW THAT CONNECTS THE TWO HALF RINGS ON ONE OF THE SYNFRAME HALF RINGS COLD WELDED AND THE STAFF STRIPPED THE SCREWDRIVER TRYING TO REMOVE IT. THE TIP OF THE HALF RING BROKE OFF IN THE EFFORT TO GET THE TWO RINGS APART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712164 ↗
• MalfunctionJan 8, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON DECEMBER 10,2023, THE SYNFRAME HALF RING HAS A SCREW THAT WAS STRIPPED AND NO LONGER HOLDS THE TWO HALVES TOGETHER. THE DAMAGED PRODUCT WAS GIVEN TO ME AFTER DECONTAMINATION. NO PATIENT INVOLVEMENT WAS THERE. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464754 ↗
• MalfunctionDec 27, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE NEW SYNFRAME HALF RING REQUESTED BY THE HOSPITAL COULD NOT BE TIGHTLY SEALED WITH THE LARGE HEXAGON SCREWDRIVER BELONGING TO THE SYSTEM. THE DRIVE OF THE SCREWDRIVER CANNOT BE INSERTED DEEP ENOUGH AND SLIPS OFF. A SUITABLE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN MINUTE DELAY. THIS REPORT INVOLVES ONE SYNFRAME HALF RING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398047 ↗
• MalfunctionNov 7, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE NUT HAS BEEN THREADED, UNABLE TO TIGHTEN. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) SYNFRAME HALF-RING, FOR HOLDING RING NO. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086095 ↗
• MalfunctionOct 17, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE SYNFRAME SYSTEM'S SCREWS WHICH ALLOWED THE AD-HOC BINDING BETWEEN THE 2-HALF-CIRCLES OF THE SYSTEM WAS BROKEN OR NON-FUNCTIONAL. THE SURGICAL TEAM MANAGED TO COMPLETE THE SURGERY ALTHOUGH THE SYNFRAME SYSTEM REMAINED HIGHLY UNSTABLE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) SYNFRAME HALF RING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953273 ↗
• MalfunctionOct 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE OF THE SYNFRAME SYSTEM'S SCREWS WHICH ALLOWED THE AD-HOC BINDING BETWEEN THE 2-HALF-CIRCLES OF THE SYSTEM WAS BROKEN OR NON-FUNCTIONAL. THE SURGICAL TEAM MANAGED TO COMPLETE THE SURGERY ALTHOUGH THE SYNFRAME SYSTEM REMAINED HIGHLY UNSTABLE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) SYNFRAME HALF RING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850658 ↗
• MalfunctionFeb 17, 2023Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A CLINIC VISIT THE HOLDING SET SCREWS WERE STRIPPED AND WERE NOT TIGHTENING, NOT HOLDING THE FRAME TOGETHER. IT WAS NOTICED AFTER DECONTAMINATION. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING. THIS IS REPORT 1 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397771 ↗
• MalfunctionFeb 17, 2023Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A CLINIC VISIT THE HOLDING SET SCREWS WERE STRIPPED AND WERE NOT TIGHTENING, NOT HOLDING THE FRAME TOGETHER. IT WAS NOTICED AFTER DECONTAMINATION. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397293 ↗
• MalfunctionMay 23, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING TESTING PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SCREWS ON TWO SYNFRAME HALF RING DEVICES WERE STRIPPED AND COULD NOT BE TIGHTENED DOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469028 ↗
• MalfunctionMay 23, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING TESTING PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SCREWS ON TWO SYNFRAME HALF RING DEVICES WERE STRIPPED AND COULD NOT BE TIGHTENED DOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469024 ↗
• MalfunctionJun 24, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING INSPECTION OF EQUIPMENT IN CENTRAL STERILE, IT WAS NOTICED THAT ONE OF THE SCREWS ON THE SYNFRAME HOLDING RING IS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE PAN HEAD SCREW WAS OBSERVED TO BE ASSEMBLED WITH THE SCREW, BUT COULD NOT BE DISASSEMBLED. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060055 ↗
• MalfunctionMar 23, 2021Material Integrity Problem; Material Integrity Problem

  UPDATED EVENT DESCRIPTION: DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE ATTACHMENT TO SECURE SYNFRAME RING WAS BROKEN. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR (1) IMPLANT INSERTER SH CONNECTION THIS REPORT IS 1 OF 1 PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558139 ↗
• MalfunctionNov 2, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, WHILE THE NURSE WAS PUTTING THE HALF RING TOGETHER, IT WAS NOTICED THAT THE SCREW WAS BROKEN AND UNABLE TO TIGHTEN IT ONTO THE OTHER HALF RING TIGHTLY. WHILE TIGHTENING THE BLUE HOLDING BASE TO THE BED, THE BLUE SCREW MADE A LOUD CRACK NOISE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) SYNFRAME HALF RING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10773639 ↗
• MalfunctionAug 10, 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, DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) CASE, THAT THE SYNFRAME INSTRUMENTS NEEDED TO BE LUBRICATED AND TWO (2) CLAMPS NEEDED TO BE REPLACED DUE TO THE CLAMPS NOT GRIPPING THE O-RING PROPERLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: O-RING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). SYNFRAME CLAMP F/HOLDINGRING NO. 387.336 (PART 387.347, LOT UNKNOWN, QUANTITY 1), SYNFRAME ½RING F/HOLDINGRING NO. 387.336 (PART 387.337, LOT UNKNOWN, QUANTITY 1), SYNFRAME-EXTENSION F/387.336+387.337 (PART 387.338, LOT UNKNOWN, QUANTITY 2), SYNFRAME-EXTENSION W/JOINT W/SNAP-IN LOC (PART 387.334, LOT UNKNOWN, QUANTITY 2), SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT (PART 387.358, LOT UNKNWON, QUANTITY 3). THIS REPORT INVOLVES ONE (1) SYNFRAME HALF RING. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT, (B)(4) CAPTURES 10 OF 36 DEVICES, AND IS RELATED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384590 ↗
• MalfunctionAug 10, 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, DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) CASE, THAT THE SYNFRAME INSTRUMENTS NEEDED TO BE LUBRICATED AND TWO (2) CLAMPS NEEDED TO BE REPLACED DUE TO THE CLAMPS NOT GRIPPING THE O-RING PROPERLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: O-RING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). SYNFRAME CLAMP F/HOLDINGRING NO. 387.336 (PART 387.347, LOT UNKNOWN, QUANTITY 1), SYNFRAME ½RING F/HOLDINGRING NO. 387.336 (PART 387.337, LOT UNKNOWN, QUANTITY 1), SYNFRAME-EXTENSION F/387.336+387.337 (PART 387.338, LOT UNKNOWN, QUANTITY 2), SYNFRAME-EXTENSION W/JOINT W/SNAP-IN LOC (PART 387.334, LOT UNKNOWN, QUANTITY 2), SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT (PART 387.358, LOT UNKNWON, QUANTITY 3). THIS REPORT INVOLVES ONE (1) SYNFRAME HALF RING. THIS IS REPORT 2 OF 10 FOR (B)(4) THIS COMPLAINT, (B)(4) CAPTURES 10 OF 36 DEVICES, AND IS RELATED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384549 ↗
• MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT IN ONE REQUIRED SET 8 RETRACTOR ARMS TO GO WITH THE 8 RING CLAMPS WERE REQUIRED, BUT ONLY 6 ARMS WERE SUPPLIED. IN THE SAME SET, THE 2-PIECE HALF CIRCLE RING WOULD NOT SCREW TOGETHER ON ONE SIDE. WHERE THE SCREW DRIVER ENTERS TO TIGHTEN THE SCREW, IT HAD SHREDDED AND WOULD NOT GRIP, THEREFORE RENDERING IT USELESS. IN ANOTHER SET, THE BLUE RING CLAMPS WERE NOT GRIPPING THE RETRACTOR ARMS ADEQUATELY NOR THE RING, WHICH WAS NOT HOLDING THE BLADE IN PLACE AND THEREFORE NOT PROVIDING RETRACTION. IN ADDITION, A SCREW WAS MISSING FROM THE 2 PIECE HALF CIRCLE RING. THE LAST SET WAS OPENED AND THE SAME FAILS AS ABOVE OCCURRED WITH SOME OF THE CLAMPS. THESE ISSUES IMPACTED THE ALLOCATION OF INSTRUMENTATION FOR THE REST OF THE LIST AND REQUIRED THE CSSD DEPARTMENT TO RE-STERILIZE THE HOSPITAL¿S OWN RETRACTORS IMMEDIATELY ON AN EXTREMELY BUSY DAY. THIS REPORT IS FOR A SYNFRAME HALF RING. THIS IS REPORT 2 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10039065 ↗