MAUDE Adverse Event Report: ZIMMER SPINE OPTIO-C PLATE, 7MM

Model Number 07.01873.007

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be reported upon further investigation of event details.

Event Description

Same case as: 2184052-2015-00130.It was reported that an optio-c peek interbody and optio-c plate disassembled postoperatively.The patient underwent a two level cervical interbody fusion procedure.Implantation at c6-c7 involved an extreme angle and the peek was not clearly visible on lateral intra-operative x-rays, but the plate and screws looked fine.Three (3) days post-operatively, x-ray imaging revealed that the optio-c cage and plate at c6-c7 appeared to be disassembled.The patient is reported to be doing well postoperatively and is being monitored; no other postoperative issues have been reported.

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.Review of all provided information concluded that there is no evidence of a product defect or deficiency.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: OPTIO-C PLATE, 7MM
• Type of Device: OPTIO-C PLATE, 7MM
• 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: 5251128
• MDR Text Key: 32262628
• Report Number: 2184052-2015-00129
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.01873.007
• Device Catalogue Number: 07.01873.007
• Device Lot Number: 62640091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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