MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT LUMBAR SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	5384254
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device returned for evaluation.No radiographs provided to confirm the event.Un-retrieved fragment from index surgery was left in-situ per surgeon's discretion and interbody spacer was discarded at the facility.Complaint could not be confirmed and no root cause could be determined.No patient injury reported.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 nonunion or delayed union".".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic and internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.".
Event or Problem Description
On (b)(6) 2016, a patient underwent a transforaminal lumbar interbody fusion at l4-l5 disc space, during insertion the inserter tang broke off and was not retrieved.No patient injury reported.During a later follow up visit radiographs showed the interbody spacer had migrated.On (b)(6) 2017 a revision procedure took place where the migrated spacer was replaced however the previously un-retrieved inserter fragment was again left in-situ.No patient injury reported.

• Brand Name: NUVASIVE COROENT LUMBAR SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6654290
• Report Number: 2031966-2017-00073
• Device Sequence Number: 1285196
• Product Code: MAX
• UDI-Device Identifier: 00887517620620
• UDI-Public: 00887517620620
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

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: 5384254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1