Precept 8800000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887517344076), received between Dec 21, 2015 and Mar 5, 2020 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON AN UNKNOWN DATE A PATIENT UNDERWENT A SINGLE LEVEL POSTERIOR FIXATION PROCEDURE WITH NO REPORTED ISSUES. POST-OPERATIVE, A SET SCREW WAS IDENTIFIED AS DETACHED. ON (B)(6) 2020 A REVISION PROCEDURE TOOK PLACE. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9794715 ↗
• MalfunctionDec 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2017, PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4/5 LEVELS WITH POSTERIOR FIXATION. FOLLOW UP RADIOGRAPHS CONFIRMED A SET SCREW BACK OUT AT RIGHT SIDE OF L4 LEVEL. A REVISION PROCEDURE IS BEING PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166289 ↗
• MalfunctionNov 9, 2018Unintended Movement; Migration; Unintended Movement; Migration

  ON (B)(6) 2018, PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S1 LEVELS. ON (B)(6) 2018 A SET SCREW BACK OUT WAS IDENTIFIED. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 WHERE THE SET SCREW WAS REPLACED WITH NO REPORTED ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8056922 ↗
• MalfunctionJul 5, 2017Unintended Movement; Unintended Movement

  ON (B)(6) 2017, A REVISION SURGERY OCCURRED DUE TO BACK OUT OF THE LEFT SIDE S1 LEVEL SCREW. THE S1 SCREW WAS LEFT IN SITU AND THE CONSTRUCT WAS EXTENDED. IT WAS REPORTED THAT PATIENT UNDERWENT A SUBSEQUENT SURGERY ON (B)(6) 2017, DUE TO BACK OUT OF THE S1 SCREW ON THE RIGHT SIDE. THE S1 SCREW WAS LEFT IN SITU AND THE CONSTRUCT WAS EXTENDED AND ANOTHER SCREW WAS PLACED ON THE LEFT SIDE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6686377 ↗
• MalfunctionJul 5, 2017Unintended Movement; Unintended Movement

  ON (B)(6) 2017, A REVISION SURGERY OCCURRED DUE TO BACK OUT OF THE S1 SCREW ON THE LEFT SIDE. THE S1 SCREW WAS LEFT IN SITU AND THE LEFT SIDE OF THE CONSTRUCT WAS EXTENDED TO THE S2AI LEVEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6686376 ↗
• MalfunctionMay 9, 2017Detachment Of Device Component; Unintended Movement; Detachment Of Device Component; Unintended Movement

  ON (B)(6) 2016 A (B)(6) MALE UNDERWENT A PROCEDURE WITH POSTERIOR FIXATION FROM T10 TO L1 WITHOUT ISSUE. DURING A SUBSEQUENT ROUTINE CHECKUP (DATE UNKNOWN) RADIOGRAPHIC IMAGES SHOWED A LOCK SCREW AT T10 HAD BACKED OUT. NO REVISION HAS BEEN PLANNED. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC AND NO INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6553660 ↗
• MalfunctionMay 9, 2017Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  ON (B)(6) 2016 A (B)(6) Y/O MALE UNDERWENT A TWO LEVEL DISCECTOMY WITH INTERBODY SPACERS AND POSTERIOR FIXATION FROM S1 TO L4 WITHOUT COMPLICATION. ON (B)(6) 2017 DURING A ROUTINE CHECKUP RADIOGRAPHIC IMAGES SHOWED A LOCK SCREW AT L4 HAD LOOSENED. NO REVISION IS PLANNED. THE PATIENT IS ASYMPTOMATIC AND NO INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6553623 ↗
• MalfunctionMay 4, 2017Unintended Movement; Unintended Movement

  ON (B)(6) 2017 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AS AN ADDITION TO AN EXISTING CONSTRUCT AT L2-L5. DURING THE PROCEDURE IT WAS OBSERVED THAT LOCKS SCREWS IN THE EXISTING CONSTRUCT HAD LOOSENED. THE EXISTING CONSTRUCT WAS REMOVED AND REPLACED WITH THE ADDITIONAL LEVELS WITHOUT REPORTED ISSUE. NO INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6543323 ↗
• MalfunctionApr 6, 2017Detachment Of Device Component; Unintended Movement; Detachment Of Device Component; Unintended Movement

  ON 03/13/2017 NUVASIVE WAS NOTIFIED OF A POST-OPERATIVE EVENT IN WHICH POSTERIOR FIXATION COMPONENT(S) WERE REPORTED TO HAVE LOOSENED. NO PATIENT INJURY HAS BEEN REPORTED. NO INTERVENTIONS TO CORRECT THE CONSTRUCT FAULT ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 6464899 ↗
• MalfunctionDec 2, 2016Detachment Of Device Component; Detachment Of Device Component

  IN (B)(6) 2011 A (B)(6) MALE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. THE PATIENT COMPLAINED OF PAIN IN (B)(6) 2016 AND X-RAYS REVEALED ONE OF THE SET SCREWS HAD LOOSENED. ON (B)(6) 2016 A REVISION PROCEDURE WAS COMPLETED TO REPLACE THE LOOSENED COMPONENTS. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6143144 ↗
• MalfunctionSep 6, 2016Detachment Of Device Component; Detachment Of Device Component

  FOLLOWING IMPLANTATION OF A LATERAL FUSION/POSTERIOR FIXATION CONSTRUCT ON (B)(6) 2016, IT WAS NOTED THAT THE RIGHT L4 LOCK SCREW HAD SEPARATED FROM THE POLYAXIAL SCREW. THIS WAS NOTED ON (B)(6) 2016. REVISION SURGERY TO CORRECT THE COMPONENT SEPARATION OCCURRED SHORTLY THEREAFTER IN WHICH THE ROD AND LOCK SCREW WERE REPLACED. NO INJURY IS KNOWN TO HAVE OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 5931189 ↗
• MalfunctionMar 8, 2016Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  ON (B)(6) 2015 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM S1 TO L1 WITH NO PROBLEMS REPORTED. DURING A LATER FOLLOW-UP VISIT AND RADIOGRAPHIC REVIEW, THE RIGHT-SIDE LOCKSCREW AT S1 WAS NOTED TO HAVE LOOSENED. ON (B)(6) 2016 A REVISION PROCEDURE WAS PERFORMED REPLACING THE SCREW AND LOCKSCREW AT RIGHT-SIDE S1, AS WELL AS BOTH CONNECTING RODS. NO FURTHER PROBLEMS HAVE BEEN REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5487987 ↗
• MalfunctionDec 21, 2015Detachment Of Device Component; Mechanical Problem

  ON (B)(6) 2015 A PATIENT UNDERWENT A LUMBAR POSTERIOR FIXATION AT L4-L5. AFTER SURGERY EXAMINATION NOTED DISASSOCIATION OF THE SET SCREW AT RIGHT L4. REVISION SURGERY OCCURRED ON (B)(6) 2015 AND THE SET SCREW WAS REPLACED. NO PATIENT INJURY IS KNOWN TO HAVE OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 5316009 ↗