UCR 10-1045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981029432), received between May 26, 2017 and Aug 21, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K043232); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2019Break; Mechanical Problem; Break; Mechanical Problem

  INDEX PROCEDURE WAS A T10 ILIUM DEGEN SCOLI CASE FROM (B)(6) 2016. IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP THAT A ROD WAS BROKEN. ON (B)(6) 2019 PATIENT UNDERWENT REVISION SURGERY FOR ROD BREAKAGE AT THE CAUDAL END OF THE CONSTRUCT BETWEEN L5-S1. THE REVISION CONSISTED OF CUTTING THE ROD, REMOVING A SCREW AND EXTENDING THE LATERAL CONNECTORS TO T4. NO PATIENT INJURY REPORTED WITH THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 8916099 ↗
• MalfunctionMay 26, 2017Fracture; Mechanical Problem; Fracture; Mechanical Problem

  ON (B)(6) 2015 PATIENT UNDERWENT REVISION SURGERY FOR ROD SLIPPAGE AT THE CAUDAL END OF THE CONSTRUCT. THE REVISION SURGERY ALSO INCLUDED A PEDICLE SUBTRACTION OSTEOTOMY (PSO) TO CORRECT FLAT BACK AND TO EXTEND THE CONSTRUCT ONE LEVEL TO S2. PATIENT CONTINUED TREATMENT FOR 18 MORE MONTHS. ON (B)(6) 2017, PATIENT HEARD POP SOUND AND A POST-OPERATIVE EXAMINATION CONFIRMED THE ROD BREAK AT L2 . PATIENT INDICATED SHE DIDN'T ACHIEVE SOLID FUSION IN L2. NO CORRECTIVE ACTION SUCH AS REVISION SURGERY HAS OCCURRED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6595973 ↗
• MalfunctionMay 26, 2017Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ON (B)(6) 2015 PATIENT RECEIVED INDEX SURGERY (EIGHT LEVEL CONSTRUCT T10-S1) TO ADDRESS ADJACENT SEGMENT DISEASE. IN (B)(6) 2015 THE CONSTRUCT WAS NOTED TO HAVE A ROD SLIPPAGE AT THE CAUDAL END OF THE CONSTRUCT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 INVOLVING A PEDICLE SUBTRACTION OSTEOTOMY (PSO) TO CORRECT FLAT BACK AND TO EXTEND THE CONSTRUCT TO S2. PATIENT CONTINUED TREATMENT FOR 18 MORE MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 6595933 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043232. One submission often covers many models, so check the product and lot details in each record.

• Z-1841-2014 · May 21, 2014 · Terminated
  Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with t