Precept 8806545ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887517450654), received between Dec 20, 2015 and Jan 22, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT A SURGICAL PROCEDURE TO ADDRESS A FRACTURE ON THE T12 VERTEBRAL BODY WITH NO REPORTED INCIDENTS. TWO WEEKS POST-OPERATIVE X-RAYS FILMS SHOWED SCREW(S) BACK OUT. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 8267780 ↗
• MalfunctionJan 21, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT A SURGICAL PROCEDURE TO ADDRESS A FRACTURE ON THE T12 VERTEBRAL BODY WITH NO REPORTED INCIDENTS. TWO WEEKS POST-OPERATIVE X-RAYS SHOWED SCREW(S) SCREW BACK OUT. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 8265817 ↗
• InjuryJan 21, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT A SURGICAL PROCEDURE TO ADDRESS A FRACTURE OF THE L3 VERTEBRAL BODY WITH NO REPORTED INCIDENTS. TWO WEEKS POST-OPERATIVE X-RAYS FILMS INDICATED THE RIGHT SIDE LUMBAR SCREW AT THE L4 LEVEL HAD PULLED OUT AND THERE WAS A COLLAPSE OF THE FRACTURE AT THE L3 LEVEL. NO REVISION PROCEDURE IS PLANNED AT THIS TIME AS PATIENT IS ASYMPTOMATIC.

  Patient problems: Failure of Implant

  MAUDE report 8265634 ↗
• MalfunctionJan 21, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT A SURGICAL PROCEDURE TO ADDRESS A FRACTURE OF THE L1 AND L2 VERTEBRAL BODIES WITH NO REPORTED INCIDENTS. TWO WEEKS POST-OPERATIVE X-RAYS SHOWED THE RIGHT SIDE LUMBAR SCREW(S) HAD PULLED OUT. PATIENT UNDERWENT A REVISION PROCEDURE WHERE SCREWS WERE REPLACED WITH FENESTRATED SCREWS. PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 8264993 ↗
• MalfunctionJan 21, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018 PATIENT UNDERWENT AN UNKNOWN SPINE PROCEDURE. TWO WEEKS POST-OPERATIVE FILMS IDENTIFIED SCREW BACK OUTS. PATIENT IS ASYMPTOMATIC AND NO REVISION PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 8264799 ↗
• MalfunctionDec 20, 2015Loose or Intermittent Connection; Detachment of Device or Device Component

  ON (B)(6) 2014 A (B)(6) MALE HAD POLYAXIAL SPINAL SCREWS PLACED AT L2-L5 AND L5-S1. SEVEN MONTHS POST-OP, PATIENT RETURNED STATING THEY WERE IN PAIN AND COULD HEAR AN AUDIBLE SQUEAKING WHEN MOVING. SURGEON PERFORMED EXPLORATORY SURGERY ON (B)(6) 2015 AND FOUND THAT THE RIGHT SIDE OF THE POLYAXIAL SCREW HEADS WERE NO LONGER TIGHT AND THAT THE ROD HAD LOOSENED. THE SCREWS AND ROD WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5312945 ↗