MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT LARGE MP INSERTER, LARGE; INTERBODY SPACER INSERTER

Model Number	6020001
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Device Slipped (1584); Unintended Movement (3026)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the returned instrument noted weld fracture not previously observed.Exemplar testing of same lot indicates weld strength is well above specified threshold.The fracture prevented final placement in optimal position.Subsequent loosening of the implant occurred.Removal of the anterior annulus may have occurred as well, thus providing a path into the peritoneum.Labeling review.Ifu review.".As with any major surgical procedure, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications.May result in the need for additional surgeries.".
Event or Problem Description
On (b)(6) 2017 a (b)(6) male patient underwent a posterior discectomy and fusion procedure.During the procedure the steel sheath on the inserter reportedly fractured.As a result the implant would not rotate to the proper orientation causing it to disengage from the inserter.The attempts to move/place the implant led to anterior migration into the peritoneum.On (b)(6) 2017 the patient underwent a diagnostic laproscopy for retrieval of the migrated implant.The patient is recovering well post-reoperation.

• Brand Name: NUVASIVE COROENT LARGE MP INSERTER, LARGE
• Common Device Name: INTERBODY SPACER INSERTER
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6443766
• Report Number: 2031966-2017-00024
• Device Sequence Number: 16297239
• Product Code: MAX
• UDI-Device Identifier: 00887517278050
• UDI-Public: 00887517278050
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

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: 6020001
• Device Lot Number: TU4516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR