MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE® VERSATIE SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number	8510260
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Spinal Column Injury (2081)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned and tested according to specifications.No radiographs or images were provided to confirm the alleged event.As per reporter the band positioning was higher than intended and recommended creating excessive prying force.Even though root cause cannot be confirmed, root cause may be related a procedural error.Follow up technique variation has been provided to involved staff.No product failure was identified.Labeling review: ".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Potential risks identified with the use of this system, which may require additional surgery, include: ¿ disassembly, fraying, kinking, loosening, bending or breakage of any or all of the versatie system implant components ¿ loss of fixation ¿ nonunion or delayed union ¿ fracture of the vertebra." ".Step 1: create spinous process hole use the provided bone punch or 3.5 mm burr to create a hole in the spinous process once the screws are placed, prior to inserting the rod.Once the hole has been created, the rod can then be placed (fig.9).Step 2: load connector reference sub-laminar fixation step 1.Step 3: pass band pass the needle tip of the band through the newly created hole.Use the needle driver to grip the thick rope portion (not the needle), and pull the band laterally through until both ends are even (fig.10).Tip when using the bone punch, place the tips on either side of the spinous process as ventral as possible, squeeze the arms, and rock the instrument in the cranial/caudal direction to create a through hole.".
Event or Problem Description
On (b)(6) 2019 a patient underwent a posterior fixation procedure utilizing the versatie system.As per reporter while tension was being performed the band ripped the spinous process.The surgeon moved to the next level and the same thing occurred.Alternative fixation device was utilized.The patient was reported to have re-cooperated.

• Brand Name: NUVASIVE® VERSATIE SYSTEM
• Common Device Name: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8547866
• Report Number: 2031966-2019-00187
• Device Sequence Number: 16755081
• Product Code: OWI
• UDI-Device Identifier: 00887517709875
• UDI-Public: 887517709875
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: Health Professional
• Device Model Number: 8510260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8450001 BAND; 8510260 CLAMP
• Outcome Attributed to Adverse Event: Other