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

Model Number	13116545
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were radiographs provided to confirm the reported event.It was reported screws removed from l2 were placed in l1 level.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." 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." single use: ".Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents.Resterilization may result in damage or decreased performance." post-operative warnings ".Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications." no product returned for evaluation.
Event or Problem Description
On (b)(6) 2018, a patient underwent an extreme lateral interbody fusion procedure at l2-l5 and posterior fusion procedure at l2-iliac levels.Reportedly, on (b)(6) 2018, it was confirmed that the left l3 and l4 screws had penetrated the inner bone and the left iliac screw had also penetrated the outer table of the ilium.On (b)(6) 2018 patient underwent a revision procedure where the left l3, l4 and iliac screws were replaced.Screws on the l2 level were found to be loose and were replaced with 7.5mm screws, the screws removed were placed at the l1 level.

• 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: 7423427
• Report Number: 2031966-2018-00035
• Device Sequence Number: 1740277
• Product Code: NKB
• UDI-Device Identifier: 00887517582508
• UDI-Public: 00887517582508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: Physician
• Device Model Number: 13116545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR