Precept 8801069Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887517346964), received between Mar 31, 2021 and Apr 23, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Fracture

  IT WAS REPORTED THAT WHEN THE SURGEON INSERTED SCREW AT S2AI, THE SCREW WAS DEVIATED ALTHOUGH THE GUIDE WIRE USED. HE TRIED REMOVE THE SCREW, BUT THE GUIDE WIRE FRACTURED. THE FRAGMENT OF THE WIRE REMAINED INTO THE BODY AND BLEEDING OCCURRED. THE SURGEON INTERRUPTED SURGERY AND TRANSFERRED THE PATIENT TO THE ANGIOGRAPHY ROOM. AFTER THAT, THE PLANED SURGERY WAS CANCELED. A REVISION SURGERY OCCURRED ON (B)(6) 2026. THE SURGEON REMOVED THE FRAGMENT OF THE WIRE AND COMPLETED SPINAL FIXATION. THE FRAGMENT OF WIRE REMOVED WAS DISCARDED. NO ADVERSE EFFECT REPORTED FOLLOWING THE REVISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24966609 ↗
• MalfunctionSep 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A PRECEPT K-WIRE BROKE OFF AND WAS LEFT IN THE BONE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23121674 ↗
• MalfunctionJun 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4 TO S1. DURING THE PROCEDURE, A KIRSCHNER WIRE (K-WIRE) WAS INSERTED INTO THE LEFT S1 AND WAS BENT DURING THE PLACEMENT OF THE PEDICLE SCREW OVER THE WIRE. SUBSEQUENTLY, THE DISTAL TIP OF THE K-WIRE FRACTURED WITHIN THE VERTEBRAL BODY AND WAS UNABLE TO BE REMOVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19515819 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THREE (3) LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION FROM L2 TO L5. DURING THE PROCEDURE, A KIRSCHNER WIRE (K-WIRE) WAS INSERTED INTO L2 AND THE PEDICLE SCREW WAS INSERTED OVER THE WIRE. SUBSEQUENTLY, THE K-WIRE WAS ATTEMPTED TO BE REMOVED WHEN IT WAS NOTED TO BE CAUGHT ON THE TIP OF THE PEDICLE SCREW. DURING SEVERAL ATTEMPTS TO REMOVE THE K-WIRE, THE DISTAL TIP FRACTURED WITHIN THE VERTEBRAL BODY AND WAS UNABLE TO BE REMOVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18031708 ↗
• MalfunctionJun 14, 2023Fracture; Fracture

  N/A.

  Patient problems: Foreign Body In Patient

  MAUDE report 17128496 ↗
• MalfunctionMay 10, 2023Fracture; Fracture

  N/A.

  Patient problems: Foreign Body In Patient

  MAUDE report 16906750 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL POSTERIOR FIXATION PROCEDURE FROM L2 TO L5. DURING THE PROCEDURE, UPON REMOVAL OF THE KIRSCHNER WIRE (K-WIRE) FROM THE RIGHT L3 VERTEBRAE, IT WAS NOTED THAT THE DISTAL TIP HAD FRACTURED OFF AND APPROXIMATELY ONE (1) CM REMAINED WITHIN THE VERTEBRAL BODY. THE FRACTURED PORTION WAS UNABLE TO BE RETRIEVED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16133900 ↗
• MalfunctionNov 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL POSTERIOR FIXATION PROCEDURE FROM L2 TO L5. DURING THE PROCEDURE, A KIRSCHNER WIRE (K-WIRE) WAS PLACED IN THE PEDICLE BONE AT L3 TO FACILITATE INSERTION OF THE PEDICLE SCREW. SUBSEQUENTLY, THE DISTAL TIP OF THE K-WIRE FRACTURED OFF UPON REMOVAL AND WAS UNABLE TO BE RETRIEVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15821087 ↗
• MalfunctionMar 31, 2021Fracture; Fracture

  A 1. 5MM PIECE OF K-WIRE BROKE OFF IN PATIENT'S SACRUM DURING A SPINAL CASE. SURGEON WAS ATTEMPTING TO DRILL K-WIRE INTO SACRUM.

  Patient problems: Foreign Body In Patient

  MAUDE report 11595856 ↗