MAUDE Adverse Event Report: NUVASIVE, INC. UNIVERSAL INSERTER, COROENT XL; INTERBODY SPACER INSERTER

Model Number	6900101
Medical Device Problem Codes	Device Slipped (1584); Unintended Movement (3026)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information obtained regarding the potential peritoneal breach is insufficient to determine the cause of the event.The instrument was evaluated and determined to exhibit some minor thread damage that did not affect functionality when the device was evaluated.It is not clear that this instrument was involved in the reported injury.Manufacturing review: review of the device history record notes no material nonconformances, manufacturing errors nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this event type.The instrument met acceptance criteria upon release.Labeling review "potential risks identified with the use of this system, which may require additional surgery, include." "neurological, vascular or visceral injury.".
Event or Problem Description
On (b)(6) 2017 a female patient (b)(6) underwent a procedure on l3 to l4 levels.In the initial surgery the implant was placed without issue but the surgeon believed he may have breached the peritoneum.As a result he opted to remove and replace the implant during a revision surgery on (b)(6) 2017.The cage was removed and replaced without further incident to the patient.

• Brand Name: UNIVERSAL INSERTER, COROENT XL
• Common Device Name: INTERBODY SPACER INSERTER
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6452427
• Report Number: 2031966-2017-00033
• Device Sequence Number: 875385
• Product Code: MAX
• UDI-Device Identifier: 00887517382351
• UDI-Public: 00887517382351
• 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): 04/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 6900101
• Device Lot Number: EM0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR