MAUDE Adverse Event Report: NUVASIVE, INC. SPINOUS PROCESS PLATE SYSTEM; APPLIANCE,FIXATION, SPINAL INTERLAMINAL

Model Number	7577045
Medical Device Problem Codes	Unstable (1667); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation nor were x-ray films provided to confirm the reported event.Eventhough root cause cannot be confirmed information received indicates event may be related to non-union "pseudoarthrosis".Potential adverse events and complications "as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s) nonunion or delayed union." "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." post-operative warnings "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
Event or Problem Description
On (b)(6) 2011, a patient underwent an interlaminar lumbar instrumented fusion at l4-5 levels.On (b)(6) 2013, during a 24 month visit it was reported "implant failure, instability; pseudoarthrosis".No further information was provided.

• Brand Name: SPINOUS PROCESS PLATE SYSTEM
• Common Device Name: APPLIANCE,FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6979704
• Report Number: 2031966-2017-00142
• Device Sequence Number: 1345232
• Product Code: KWP
• UDI-Device Identifier: 00887517062352
• UDI-Public: 00887517062352
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K073278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 7577045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2013
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR