N/A 8756481Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00681490520133), received between Jul 9, 2020 and Apr 20, 2023 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE WHEN AN ATTEMPT WAS MADE TO OPEN THE PIN DISTRACTOR, THE JOINT PART DETACHED. A DEFECT OCCURRED WHEN AN ATTEMPT WAS MADE TO INSERT A PIN INTO THE PATIENT, INSTALL THE DISTRACTOR, AND OPERATE THE DEVICE. HOWEVER, THE PATIENT WAS NOT AFFECTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. HENCE, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775379 ↗
• MalfunctionApr 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DISTRACTOR USED IN SPINAL THERAPY FOR CERVICAL HERNIA. LEVELS IMPLANTED: C6/7 IT WAS REPORTED THAT THE INSTRUMENT BROKE WHEN A PIN DISTRACTOR WAS USED IN C6/7. THERE WAS A DELAY OF LESS THAN 60 MINS. THE PRODUCT WAS USED ON THE PATIENT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775232 ↗
• MalfunctionFeb 6, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN CERVICAL SURGERY SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE ARE NO FURTHER PATIENT COMPLICATIONS OR SYMPTOMS WERE REPORTED DUE TO THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WAS USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302552 ↗
• MalfunctionJan 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A DEVICE US ED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS UNSOLDERED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS BROKEN. PRE-OP DIAGNOSIS WAS CERVICAL DISECTOM, PROCEDURE INVOLVED WAS CERVICAL CAGE PLACEMENT, LEVELS IMPLANTED WERE C3 TO C4. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128823 ↗
• MalfunctionJan 5, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICE USED IN ANTERIOR CERVICAL DISCECTOMY AND FUSION(ACDF) FOR A PATIENT. IT WAS REPORTED THAT THE INCISION AND RETRACTOR BLADES FROM TRIMLINE WAS PUT INTO PLACE. THE DISTRACTOR PINS WERE PUT INTO PLACE ONCE THE LEVEL WAS CONFIRMED. UPON PLACING THE DISTRACTOR ONTO THE PINS AND DISTRACTING WAS DONE, THE DISTRACTOR BROKE HALFWAY. THE TENSION BETWEEN THE PINS WAS VERY HIGH. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS DISC COMPRESSION INDICATED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION(ACDF). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101030 ↗
• MalfunctionDec 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT DISTRACTOR LEG BROKE WHEN DISTRACTING. INSTRUMENT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF INSTRUMENT REMAINING IN THE PATIENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO SYMPTOMS TO PATIENT REPORTED. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067613 ↗
• MalfunctionDec 2, 2022Break; 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 ACDF AT C6/7 FOR A CSM. IT WAS REPORTED THAT THE WELDING PART OF THE DISTRACTOR BROKE WHEN ADVANCING IN THE OPEN DIRECTION. THE EVENT OCCURRED DURING USE ON THE PATIENT. THE DISTRACTOR WAS REPLACED BY ANOTHER ONE. THERE WERE NO 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 15903636 ↗
• MalfunctionOct 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DISTRACTOR USED IN C5/6 ANTERIOR CERVICAL FUSION OF 1 INTERVERTEBRAL VERTEBRAE FOR CERVICAL HERNIA. IT WAS REPORTED THAT WHEN THE LEFT DISTRACTOR WAS INSTALLED AND THE DISTRACTION WAS APPLIED, THE WELDING PART OF THE DISTRACTOR BROKE. THERE WAS ABSOLUTELY NO APPEARANCE OF DISTRACTION BEING APPLIED WITH EXCESSIVE FORCE. NO PATIENT SYMPTOMS WERE REPORTED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585108 ↗
• 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 15416253 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL ARTIFI CIAL DISC REPLACEMENT SURGERY FOR CSM. IT WAS REPORTED THAT THE RETRACTOR 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. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118816 ↗
• MalfunctionJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT CERVICAL ANTERIOR FUSION SPINAL THERAPY FOR C4/5 CERVICAL DISC HERNIA. IT WAS REPORTED THAT AFTER DEPLOYMENT, A PIN WAS PLACED AT C4/5. WHEN THE PRODUCT WAS TRIED TO INSTALLED AND EXPAND, THE DISTRACTOR WELD PART WAS BROKEN AND CAME OFF. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754232 ↗
• MalfunctionJun 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT C6 CORPE CTOMY SPINAL THERAPY FOR C56 CERVICAL HERNIA. IT WAS REPORTED THAT  THE PIN DISTRACTOR TUBE CAME OFF WHEN THE PINS WERE INSTALLED IN C5 AND C7 AND A DISTRACTION FORCE WAS APPLIED. THERE WERE NO FURTHER COMPLICATIONS/SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS BROKEN AND NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753937 ↗
• MalfunctionJun 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL SURGERY. PRE-OPERATIVE DIAGNOSIS WAS CERVICAL SPONDYLOTIC MYELOPATHY. PROCEDURE PERFORMED IN THE EVENT WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION IT WAS REPORTED THAT INTRA-OPERATIVELY, THE LEFT DISTRACTOR¿S WELDED PART WAS BROKEN DURING DISTRACTION, SO THE RIGHT WAS USED. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646407 ↗
• MalfunctionMay 10, 2022Break; 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 ACF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE DISTRACTOR BROKE. 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 14344869 ↗
• MalfunctionMar 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR CERVICAL MYELOPATHY. PROCEDURE PERFORMED WAS ARTIFICIAL DISC REPLACEMENT. IT WAS REPORTED THAT THE WELDING PORTION DISLODGED. 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 13855073 ↗
• MalfunctionFeb 9, 2022Break; 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 UNKNOWN SPINAL THERAPY FOR A C5/6 CAGE DIVERGENCE. IT WAS REPORTED THAT THE DISTRACTOR WAS BROKEN DURING THE SPREADING OF C5/6. THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS WAS NOT A REVISION SURGERY 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 13493412 ↗
• 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 13174126 ↗
• MalfunctionDec 29, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13106164 ↗
• 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 12858741 ↗
• 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 12833942 ↗
• 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 12818703 ↗
• 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 12568008 ↗
• MalfunctionSep 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C4/5 TDR PROCEDURE IN A PATIENT DIAGNOSED WITH CSM. IT WAS REPORTED THAT THE DISTRACTOR BROKE WHEN APPLYING DISTRACTION. THE PRODUCT WAS PLACED IN THE BODY AND IT WAS DAMAGED WHEN DISTRACTION FORCE WAS APPLIED. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431329 ↗
• MalfunctionJul 26, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL ARTHRODESIS FOR CERVICAL HERNIA. IT WAS REPORTED THAT THE TREPHINE BROKE WHILE GRAFTING THE ILIAC AND THE DISTRACTOR BROKE WHILE USING THE CASPER. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223625 ↗
• MalfunctionJun 8, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PART THROUGH WHICH THE PIN PASSES AND THE MAIN BODY PART WERE SEPARATED. THERE IS NO PATIENT INVOLVED IN THE EVENT AND PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11955870 ↗