MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	13016540
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were radiographs provided to confirm the alleged event.Labeling review: potential adverse events and complications ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).".".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.".Patient education: ".The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.".".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.".
Event or Problem Description
On (b)(6) 2018 patient underwent a revision procedure where the construct was extended and screws at s1 level were replaced.The patient was asymptomatic prior to revision procedure.No injury or adverse patient reaction has been reported.
Additional Manufacturer Narrative
Product was received and evaluation could not confirm the alleged event.A review of the explanted material show mild to moderate damage to several components of the device that tends to be consistent with implantation and the subsequent removal but not to product malfunction.No bone quality test nor patient's post-operative activity levels were reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7722485
• Report Number: 2031966-2018-00122
• Device Sequence Number: 11025566
• Product Code: NKB
• UDI-Device Identifier: 00887517537201
• UDI-Public: 00887517537201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: Health Professional
• Device Model Number: 13016540
• Device Lot Number: JP14011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR