MAUDE Adverse Event Report: ZIMMER SPINE OPTIO-C PLATE, 6MM

Model Number 07.01873.006

Device Problem Disassembly (1168)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The information contained herein is being provided to the fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.

Event Description

It was reported that while attaching the inserter to the optio-c peek interbody and plate assembly, the peek interbody and plate disassembled.The patient underwent a cervical interbody fusion procedure for an unknown reason.After the first attempt in which the peek interbody and plate disassembled, the surgeon reassembled the optio-c peek interbody and plate, and attached it to the inserter.The surgery was completed with the optio-c assembly and it remains implanted in the patient.No postoperative patient conditions have been reported.Additional information will be submitted upon receipt.

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.Review of all records for this device and 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, 6MM
• Type of Device: OPTIO-C PLATE, 6MM
• 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: 5262684
• MDR Text Key: 32788314
• Report Number: 2184052-2015-00133
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132894
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.01873.006
• Device Catalogue Number: 07.01873.006
• Device Lot Number: 62783810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2014
• 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