General instrumentation IG008RRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03662663002530), received between May 10, 2021 and Dec 22, 2025 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT A ROI-C DISTRACTION PIN BROKE INTRA-OPERATIVELY IN THE PATIENT'S VERTEBRAL BODY. THERE WAS A DELAY WITHIN THE PROCEDURE TO DRILL OUT THE TIP OF THE PIN AND THE TIP WAS SUCCESSFULLY REMOVED. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872554 ↗
• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED IN THE PATIENT'S VERTEBRA INTRA-OPERATIVELY. ADDITIONAL PATIENT AND CLINICAL INFORMATION IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22532694 ↗
• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED IN THE PATIENT'S VERTEBRA INTRA-OPERATIVELY. THE SURGEON WAS ABLE TO RETRIEVE IT AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532606 ↗
• MalfunctionJun 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DISTRACTION PIN FRACTURED INSIDE A PATIENT INTRA-OPERATIVELY, BUT WAS SUBSEQUENTLY REMOVED, AND THE SURGERY WAS COMPLETED USING A SPARE PIN WITHOUT THE INCIDENT LEADING TO ANY PATIENT HARM OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198100 ↗
• MalfunctionApr 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED INTRA-OPERATIVELY AT C4. THERE WAS A 20 MINUTE PROCEDURAL DELAY WHILE THE SURGEON REMOVED PART OF THE VERTEBRAL BODY TO A DEPTH OF 4 MM TO BE ABLE TO GRIP THE END OF THE FRACTURED PIECE AND REMOVE IT. POST-OPERATIVE MONITORING IS IN PLACE FOR A LOW RISK OF VERTEBRAL BODY FRACTURE AND BONE BLEEDING.

  Patient problems: Spinal Column Injury

  MAUDE report 21763386 ↗
• InjuryMar 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A CERVICAL ARTHRODESIS PROCEDURE USING ROI-C EQUIPMENT, A DISTRACTION PIN BROKE OFF IN THE PATIENT'S VERTEBRAL BODY, AND THE FRACTURED PIECE WAS RETAINED. THE SURGERY WAS NOT DELAYED, AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21573788 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A MOBI-C RETRACTOR FIXATION PIN FRACTURED DURING SURGERY. THE SURGEON WAS ABLE TO RETRIEVE THE PIN AND A RESERVE PIN WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549648 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED INTRA-OPERATIVELY. THE THREADED PORTION OF THE PIN WAS RETRIEVED FROM THE VERTEBRAL BODY USING A TREPHINE. NO FRAGMENTS WERE RETAINED BY THE PATIENT AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403145 ↗
• MalfunctionJul 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN BROKE IN A PATIENT. THE HOSPITAL DID NOT PROVIDE PATIENT OR SURGICAL INFORMATION AND IT IS CURRENTLY UNCLEAR WHETHER THE DEVICE WAS RETAINED OR RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 19693492 ↗
• MalfunctionMay 30, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING IMPACTION, TWO CASPAR PINS BENT AND ENDED UP BREAKING AT THE TIP. THE TIPS WERE RETRIEVED AND OTHER PINS IN THE BOX WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19430704 ↗
• MalfunctionMay 30, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING IMPACTION, TWO CASPAR PINS BENT AND ENDED UP BREAKING AT THE TIP. THE TIPS WERE RETRIEVED AND OTHER PINS IN THE BOX WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19430585 ↗
• InjuryFeb 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ROI-C SURGERY, A RETRACTOR FIXATION PIN FRACTURED AND THE THREADED PORTION COULD NOT BE RETRIEVED AND REMAINS IMPLANTED IN THE PATIENT. THERE HAVE NOT BEEN ANY PATIENT IMPACTS REPORTED TO DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18767730 ↗
• MalfunctionJun 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR PIN FRACTURED WHILE BEING REMOVED FROM THE VERTEBRAL BODY AT THE END OF SURGERY. THE FRACTURED PIECE WAS RETRIEVED. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082866 ↗
• MalfunctionJun 5, 2023Fracture; Positioning Problem; Fracture; Positioning Problem

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN BROKE DURING SURGERY AFTER THE SURGEON HAD DIFFICULTY IN POSITIONING IT IN THE CORRECT ALIGNMENT BECAUSE THE PATIENT'S ANATOMY WOULD NOT ALLOW FOR PROPER POSITIONING. THE BROKEN PIECE WAS RECOVERED AND THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066089 ↗
• InjuryFeb 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHRODESIS C3-C4, ONE OF THE RETRACTOR PINS BROKE CLEANLY AND A PIECE REMAINED IN THE PATIENT'S VERTEBRA. THERE IS AN INCREASED RISK OF INFECTION BECAUSE PART OF THE MATERIAL (SCREW THREAD 1CM) REMAINED IN THE PATIENT. THE PROCEDURE WAS INTERRUPTED (THERE WAS A SURGICAL DELAY). POST-OPERATIVELY, THE DEVICE FRAGMENT CAUSED SIGNIFICANT ARTIFACTS MAKING AN MRI OF THE CERVICAL SPINEUNINTERPRETABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16439093 ↗
• InjuryFeb 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DISTRACTION PIN BROKE OFF IN THE C4 VERTEBRAL BODY INTRA-OPERATIVELY AND COULD NOT BE REMOVED. THE PATIENT CANNOT UNDERGO FUTURE MRIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16397138 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT A DISTRACTION PIN BROKE INTO THE CERVICAL VERTEBRA BONE DURING REMOVAL INTRA-OPERATIVELY. THE SURGEON WAS ABLE TO REMOVE IT WITHOUT CONSEQUENCES FOR THE PATIENT AND CEMENT WAS ADDED TO THE HOLE. SURGERY WAS DELAYED FOR 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255888 ↗
• InjuryNov 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING IMPLANTATION, THE TIP OF THE DISTRACTION PIN BROKE OFF INTO THE UPPER VERTEBRA (C5). THE SURGEON WAS UNABLE TO REMOVE IT WITHOUT INJURING THE VERTEBRA. HE DECIDED TO LEAVE IT IN PLACE. THE SECOND ANCHORING PLATE CAME INTO CONFLICT WITH THAT PIECE OF THE DISTRACTION PIN THAT HAD REMAINED IN THE VERTEBRA AND BENT. SINCE THE PIN IS MADE OF STEEL, THE HOSPITAL INDICATED THE PATIENT COULD NO LONGER UNDERGO MRIS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15831005 ↗
• InjuryJul 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED INTRAOPERATIVELY WHILE THE SURGEON WAS THREADING IT INTO THE VERTEBRAL BODY. THE SURGEON HAD TO DRILL AROUND THE BROKEN PIECE TO RELEASE THE SCREW; EXTRA BONE WAS REMOVED. THERE WERE NO REPORTED PATIENT IMPACTS.

  Patient problems: Spinal Column Injury

  MAUDE report 15031578 ↗
• MalfunctionMay 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT A FIXATION PIN FRACTURED DURING DISTRACTION OF THE DISC SPACE DURING SURGERY. ANOTHER FIXATION PIN WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797776 ↗