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

Model Number	6121023
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned for evaluation.Radiographs were not received.Review of the reported surgical procedure noted anatomical conditions, distraction or endplate preparation may have contributed to the malpositioning of the implant.No malfunction of the inserter instrumentation is known to have occurred.The root cause of the reported event appears to be a procedural error.A vascular surgeon removed the malpositioned implant during revision surgery on (b)(6) 2017.Device not returned.
Event or Problem Description
On (b)(6) 2017 a (b)(6) yo female underwent a posterior bi-lateral lumbar interbody fusion at l4-5 spine level.During impaction of the left side interbody device was pushed anterolaterally past the vertebral margin into the retroperitoneal space.Surgeon discretion was to leave the malplaced interbody device in-situ and completed the procedure with an additional interbody device without further complication.A revision surgery was planned and scheduled.No patient injury was reported.

• Brand Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6390090
• Report Number: 2031966-2017-00015
• Device Sequence Number: 537582
• Product Code: MAX
• UDI-Device Identifier: 00887517289049
• UDI-Public: 00887517289049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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: 6121023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR