MAUDE Adverse Event Report: ZIMMER SPINE VIRAGE CLOSURE TOP

Model Number 07.01728.001

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional relevant information will be provided when the event analysis is complete.

Event Description

Same case as 2184052-2015-00106 and 2184052-2015-00107.It was reported that three virage closure tops backed out postoperatively.Virage instrumentation was implanted from c3 - t1 connecting to sequoia instrumentation implanted from t2-t5 during the same surgery connecting it to existing sequoia instrumentation that spans down to s1.The patient's wound opened one month post operation, and during the surgery to reclose the wound, it was reported that two virage closure tops were discovered visually in the soft tissue and retrieved.Later imaging found one more closure top in the soft tissue.The patient was revised approximately one month after the initial surgery and all three closure tops were replaced and the third closure top was retrieved from the soft tissue.No further information was provided concerning the patient's postoperative condition or outcome following the revision.

Manufacturer Narrative

Visual analysis of the returned device was consistent with the reported event.Review of information provided and analysis of the returned device concluded that there is no evidence of a product defect.Manufacturing records reviewed indicated no deviations or anomalies.It is not suspected that the product failed to meet specifications.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.

• Brand Name: VIRAGE CLOSURE TOP
• Type of Device: VIRAGE CLOSURE TOP
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: rikke hanson ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5162780
• MDR Text Key: 28820488
• Report Number: 2184052-2015-00107
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/28/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.01728.001
• Device Catalogue Number: 07.01728.001
• Device Lot Number: 62490472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention