SUMMIT 274655100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034193175), received between Aug 30, 2017 and Feb 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2022, A SMALL PIECE AT THE TIP OF THE ROD APPROXIMATOR BROKE OFF AS THE SURGEON WAS TRYING TO REDUCE A 3.5MM TI ROD AT L1-2. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. WHILE ATTEMPTING TO REMOVE A PEDICLE SCREW IN THE THORACIC SPINE, THE T20 SCREWDRIVER SHAFT STRIPPED. BOTH INSTRUMENTS WERE REMOVED FROM THE FIELD AND SENT TO DECON TO BE CLEANED AND SANITIZED. THE CASE WAS A THORACOLUMBAR REVISION, REMOVING SCREWS AT CERTAIN LEVELS AND EXTENDING UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A KERRISON APPROXIMATOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599039 ↗
• MalfunctionOct 31, 2019Break; Break

  STERILE PROCESSING DEPARTMENT NOTIFIED ME OF BROKEN INSTRUMENT (MISSING HALF ITS ¿JAW¿) IN TRAY. UNKNOWN HOW OR WHEN IT HAPPENED. REPLACEMENT URGENTLY NEEDED. CUSTOMER REFERENCE/PO/SERVICE: (B)(6). PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: REP. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9263113 ↗
• MalfunctionNov 27, 2017Break; Break

  THE SURGEON WAS TRYING TO PLACE THE REDUCER UNDER THE HEAD OF THE POLYAXIAL SCREW AND WHILE HE WAS DOING THAT, TWISTED IT LEFT AND RIGHT TO MANEUVER IT UNDER THE HEAD OF THE SCREW AND THE TIP BROKE OFF.

  Patient problems: Not Applicable

  MAUDE report 7062376 ↗
• MalfunctionAug 30, 2017Break; Break

  ATTEMPTING TO REDUCE THE ROD INTO THE MOUNTAINEER POLY SCREW HEAD, THE ROD REDUCTION PISTOL DEVICE WAS USED. THE FORCE APPLIED RESULTED IN THE "TIPS" OF THE DEVICE TO BREAK. THE TIPS WERE SMALL AND WERE UNABLE TO BE READILY RETRIEVED. A FINAL FLAT-PLATE X-RAY WAS TAKEN TO ENSURE THAT THEY WERE NOT LEFT BEHIND IN THE PATIENT. UPON X-RAY REVIEW, THE SURGEON AND RADIOLOGIST CONFIRMED NOT REMAINING PIECES REMAINED INSITU. THE SURGEON THEORIZED THAT THE SMALL LOOSE PIECES WERE MOST LIKELY SUCKED INTO THE SUCTION BANK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6831626 ↗