MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	8890000
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the explants showed signs of wear caused by motion between the rod and the screw.Deformation from radial splay indicates upward force was applied during final tightening due to construct loading.Damage to the threads most likely led to the decreased grip on the rod, and the subsequent movement between the screw and the rod.No radiographs were provided.Patient activity at the time or prior to the event is unknown.Patient's bone quality is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Review of the device history records notes no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions nor labeling that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: " potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s) loss of fixation metal sensitivity or allergic reaction to a foreign body these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant.Care should be taken to insure that all components are ideally fixated prior to closure.Confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization.Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.".
Event or Problem Description
On (b)(6) 2015 a (b)(6) male patient received a revision procedure as a result of a previously implanted precept construct making a squeaking sound during movement, when hardware was removed the left l4 screw was noted to be loosened and worn.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5355985
• Report Number: 2031966-2015-00090
• Device Sequence Number: 1062023
• Product Code: NKB
• UDI-Device Identifier: 00887517385604
• UDI-Public: 00887517385604
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8890000
• Device Lot Number: JP6944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR