N/A 8756480Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00681490520126), received between Nov 26, 2020 and Aug 22, 2023 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ACDF FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE RIGHT TRIMLINE DISTRACTOR BROKE DURING SURGERY IN THE OPERATING THEATRE. PRODUCT CAME IN PATIENT CONTACT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17593957 ↗
• MalfunctionApr 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN SPINAL THERAPY FOR CERVICAL ARTHRODESIS. IT WAS REPORTED THAT THE DEVICE WAS BROKEN AFTER THE SURGERY. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. LEVELS IMPLANTED WERE C5-C6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16699322 ↗
• MalfunctionFeb 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL SURGERY. IT WAS REPORTED THAT THE DISTRACTOR BROKE WHILE DISTRACTING. PRODUCT CAME IN PATIENT CONTACT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404275 ↗
• MalfunctionFeb 1, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DISTRACTOR IN A CERVICAL SURGERY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE DISTRACTOR WAS BROKEN AT THE WELD. THE PRODUCT WAS USED ON THE PATIENT AND THE PATIENT WAS ON THE OPERATING TABLE WHEN THE MALFUNCTION OCCURRED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276322 ↗
• MalfunctionNov 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH ANTERIOR CERVICAL C5-C6 THERAPY. IT WAS REPORTED THAT THE DISTRACTOR WAS BROKEN. PRODUCT CAME IN CONTACT WITH THE PATIENT THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15767987 ↗
• MalfunctionSep 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A DISC USING DISTRACTORS IN AN ARTIFICIAL DISC REPLACEMENT FOR A CERVICAL HERNIA AT C5/6. IT WAS REPORTED THAT AFTER DEPLOYMENT, A PIN WAS INSTALLED IN C5/6. WHEN THE TRIAL WAS INSERTED, THE DISTRACTOR WELD PART CAME OFF WHEN THE PRODUCT WAS INSTALLED AND WAS TRIED TO EXPAND. THE PRODUCT WAS REPLACED AFTERWARD BUT IT CAME OFF AGAIN AND THE 2 POINTS WERE BROKEN. ONLY 2 DISTRACTORS WERE BROKEN, THERE WERE NO DEFECTS WITH THE REMAINING 4 PRODUCTS. THE PRODUCTS WERE USED ON THE PATIENT AND THE PATIENT WAS ON THE OPERATING TABLE WHEN THE PRODUCTS MALFUNCTIONED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416262 ↗
• MalfunctionAug 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DISTRACTOR USED IN ACDF C5/6. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS CERVICAL HERNIA. IT WAS REPORTED THAT THE FRAME AND THE TUBULAR OUTER CYLINDER CAME OFF WHEN THE DISTRACTOR WAS OPENED FOR INTERVERTEBRAL DISC REMOVAL. THE PHYSICIAN MENTIONED THAT THE HANDLE WAS TURNED TOO TIGHTLY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238390 ↗
• MalfunctionAug 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHRODESIS SURGICAL TREATMENT FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE DISTRACTOR BROKE. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15231358 ↗
• MalfunctionJul 20, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DISTRACTOR IN AN ADR FOR MYELOPATHY AT C5/6. IT WAS REPORTED THAT DURING NORMAL USE, THEY TRIED TO EXPAND THE DISTRACTOR WHEN DISTRACTION WAS PERFORMED TO THE INTERVERTEBRAL SPACE AND THE DISTRACTOR PORTION THAT PASSES THROUGH THE THREAD PIN WAS BROKEN AND THE WELDED PART CAME OFF. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062576 ↗
• MalfunctionJul 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2 ACDF. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED RE GARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14997451 ↗
• MalfunctionJul 6, 2022Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA DISTRIBUTOR REGARDING A PATIENT WITH CERVICAL DISCECTOMY FOR CERVICAL DISTRACTION SPINAL THERAPY AT L4-L5. IT WAS REPORTED THAT THE DISTRACTOR WAS BROKEN INTO TWO PARTS. THERE WAS FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14927423 ↗
• MalfunctionJun 7, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR ACDF. PROCEDURE OR THERAPY PERFORMED WAS ACDF. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14613472 ↗
• MalfunctionMay 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT C5/6 ANT ERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FIXATION FOR C5/6 ADAPTATION FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) TREATMENT IN THE JUVENILE HERNIA. IT WAS REPORTED THAT WHEN DISTRACTOR PIN WAS PLACED IN THE VERTEBRAL BODY AND THE RETRACTOR WAS PLACED IN AN ATTEMPT TO DISTRACTION, AN EXTENSION OPERATION WAS PERFORMED USING AN ALTERNATIVE LEFT DISTRACTOR AND COMPLETED THE PROCEDURE WITHOUT INCIDENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE WELD ON THE PIN DISTRACTOR INSERTION PART HAS COME OFF. THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ONLY THE DISTRACTOR WAS BROKEN AND THERE WAS NO ALLEGATION AGAINST THE RETRACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14335841 ↗
• MalfunctionJan 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING DISTRACTORS IN AN ANTERIOR CERVICAL VERTEBRA DISTRACTION TECHNIQUE FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE TWO INSTRUMENTS WERE BEING USED FOR THE FIRST TIME IN SURGERY AND BROKE AGAIN. THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174124 ↗
• MalfunctionDec 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ACDF DUE TO UN KNOWN INDICATION. IT WAS REPORTED THAT DISTRACTOR BROKE. THE PRODUCT CAME IN PATIENT CONTACT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13008171 ↗
• MalfunctionNov 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), DISTRIBUTOR (DIS) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL THERAPY FOR CERVICAL HERNIA. IT WAS REPORTED THAT DURING CERVICAL ARTHRODESIS SURGERY, PHYSICIAN NEEDED TO MOVE THE SURGICAL FIELD FURTHER AWAY WITH THE DISTRACTORS, WHERE THERE WAS A SNAP, AND IT WAS OBSERVED THAT THE SOLDERS OF THE DISTRACTOR RODS CAME LOOSE. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE RETRACTORS WERE BROKEN AND NOT THE DRIVER. THERE IS NO MALFUNCTION ASSOCIATED WITH THE DRIVER. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858733 ↗
• MalfunctionNov 18, 2021Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833940 ↗
• MalfunctionNov 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE PART OF THE TUBE THROUGH WHICH THE PIN PASS BROKE. THE PART OF THE CYLINDER THROUGH WHICH THE PIN PASS ALSO BROKE, AND THEY PERFORMED DISTRACTION MANUALLY WITH A PIN DRIVER. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818674 ↗
• MalfunctionNov 2, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735612 ↗
• MalfunctionOct 4, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING UNKNOWN SPINAL THERAPY. THE PRE-OP DIAGNOSIS WAS MENTIONED AS C5/C6 CERVICAL DISC LESION. IT WAS REPORTED THAT, THE RIGHT DISTRACTOR WAS SET BEFORE THE DISCECTOMY. WHEN DISTRACTION WAS APPLIED, ONE WELDED PART OF THE SHAFT WHERE THE PIN ENTERED WAS BROKEN. THEY CHANGED TO A LEFT DISTRACTOR AND TRIED THE SAME OPERATION, BUT THE WELD PART WAS ALSO BROKEN. THE SHAFT AND BASE WERE SEPARATED. THE PRODUCTS WERE BROKEN AT THE WELD PART WHEN DISTRACTION WAS APPLIED. SINCE BOTH OF THE PRODUCTS WERE BROKEN, THEY DEALT WITH THE OPERATION WITHOUT A DISTRACTOR. THE PHYSICIAN VIEWED THAT IT WAS INTERFERING WITH THE RETRACTOR AT THE TIME OF EXPANDING, BUT DUE TO THE LOAD APPLIED FORCEFULLY AND CONTINUOUSLY, THE LOAD WAS APPLIED IN THIS WAY AND THE PRODUCTS WERE BROKEN. THERE WERE NO BROKEN FRAGMENTS OF DISTRACTOR REMAINS IN PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO SYMPTOMS TO PATIENT REPORTED. NO FURTHER COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567980 ↗
• MalfunctionSep 30, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DISTRACTOR IN AN ANTERIOR CERVICAL ARTHRODESIS PROCEDURE. IT WAS REPORTED THAT THE DISTRACTOR BROKE AND THERE WAS NO FRAGMENT REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12552973 ↗
• MalfunctionSep 20, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR C4/5 ACDF PROCEDURE. IT WAS REPORTED THAT ACDF DISTRACTOR WAS PLACED AND DAMAGED DURING APPLICATION OF DISTRACTION. IT WAS CHANGED TO ANOTHER DISTRACTOR. THE DEVICE BROKE. NO FRAGMENT WAS LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE: THE TUBULAR PART OF THE DISTRACTOR WAS SEPARATED AT THE WELDED PART. IT WAS SAID THAT THE PRODUCT WAS BROKEN WHEN AN ATTEMPT WAS MADE TO PERFORM DISTRACTION, AND EXCESSIVE FORCE WAS NOT APPLIED. THE OPERATION HAD BEEN COMPLETED BY REPLACING THE PRODUCT WITH A LEFT DISTRACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494193 ↗
• MalfunctionJul 14, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DISTRACTOR FOR AN ACDF. IT WAS REPORTED THAT AFTER INSERTING PIN DISTRACTOR PIN INTO THE VERTEBRAL BODY, A RIGHT DISTRACTOR WAS PLACED, AND AFTER A WHILE AFTER EXPENDING, THE TUBE PART AND SHAFT PART OF THE RIGHT DISTRACTOR CAME OFF, MAKING THE PRODUCT IMPOSSIBLE TO BE USED. THE PRODUCT WAS REPLACED WITH A LEFT DISTRACTOR AND THE OPERATION WAS CONTINUED, AND THERE WAS NO PROBLEM AFTER THAT. THE WELD PART WAS DAMAGED WHEN THE PRODUCT WAS EXPANDED AND AN ATTEMPT WAS MADE TO PERFORM THE INTERVERTEBRAL DISC CURETTAGE. THEREFORE, A LEFT DISTRACTOR WAS USED FOR DEALING WITH IT. THE INSTRUMENT BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE IS A DAMAGE TO THE INSTRUMENT OF MEDTRONIC USED DURING SURGERY. THERE WAS A DAMAGE TO THE COMPONENTS. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE REPORTED DISTRACTOR WAS USED IN OPERATING FIELD AND CAME IN CONTACT WITH THE PATIENT. THE PRE-OP DIAGNOSIS WAS C5-6 CERVICAL INTERVERTEBRAL DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165065 ↗
• MalfunctionMay 24, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS OF ACDF. IT WAS REPORTED THAT THE DISTRACTORS BROKE. THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS/ SYMPTOMS AS A RESULT OF THE EVENT. DELAY IN OVERALL PROCEDURE TIME WAS FEW MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON WANTED TO USE THE INSTRUMENTS, BUT THEY WERE BROKEN INTRA-OP. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED. TO USE IT BUT IT WAS BROKEN IN INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869168 ↗
• MalfunctionFeb 18, 2021Solder Joint Fracture; Solder Joint Fracture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DISTRACTOR DEVICE USED FOR ACDF PROCEDURE. IT WAS REPORTED THAT WHILE BROADENING THE INTERVERTEBRAL SPACE USING THE RIGHT DISTRACTOR, THE PART INSERTED IN THE PIN BECAME UNWELDED. WHEN IT BROKE, LEFT DISTRACTOR WAS USED, BUT THE SAME REPEATED. THERE WERE NO FRAGMENTS OF INSTRUMENTS REMAINING IN THE PATIENT'S BODY. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT. UPDATE : THE REPORTED PRODUCT BROKE AT THE WELDED PART WHILE EXPANDING AFTER INSERTING INTO THE INTERVERTEBRAL DISC SPACE. IT WAS ATTEMPTED TO EXPAND WITH A REPLACEMENT DISTRACTOR, BUT THE DISTRACTOR WAS BROKEN AS WELL. UPDATE : PRE-OPERATIVE DIAGNOSIS : ACDF AT 2 INTERVERTEBRAL DISCS AT C4/5/6 UPDATE : BOTH THE PRODUCTS WERE USED IN THE SURGERY AND CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341715 ↗