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

Model Number	13600000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays provided to confirm the reported event.Information received indicates product is being used in conjunction with another manufacturer's product.Labeling review: ".Compatibility: do not use reline system with components of other systems than armada system.Refer to the armada system instructions for use for a list of the armada system indications of use." ".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.The bulleted portion of the nose of the rod and the faceted portion of the rod (where the inserter locks down on the rod) must extend fully outside of the most inferior or most superior tulip on the construct.The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct.Cross connectors are designed specific to the rod diameter and cannot be used on the tapered section of tapered rods.If using cross connectors on tapered rods, only attach them on constant diameter rod sections." no product returned for investigation.
Event or Problem Description
A patient underwent posterior spinal fusion at l4-5 levels using medtronic legacy 5.5 (date unknown).On (b)(6) 2017, stryker pedicle screws were placed at t11-12 levels, hooks were placed at t10 level and reline-o connectors were placed at l4/5 levels, stryker 6.0 mm cocr rods were placed.Reportedly, l1-l3 levels were skipped due to spinal caries.On (b)(6) 2018, it was confirmed that one side of the rod was cranially displaced and separated from the connector.A revision procedure is planned on (b)(6) 2018, to replace the connector with stryker's connector.No patient injury has been 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: 7224865
• Report Number: 2031966-2018-00008
• Device Sequence Number: 1447899
• Product Code: NKB
• UDI-Device Identifier: 00887517551719
• UDI-Public: 00887517551719
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

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: 13600000
• Device Lot Number: NU18061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1