MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPTIO-C, PLATE, 7MM; OPTIO-C ANTERIOR CERVICAL SYSTEM

Catalog Number 07.01873.007

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2020-00452.

Event Description

It was reported that during the procedure the optio-c interbody and the plate were loose and did not securely fit together.The surgeon implanted the devices but when he removed them to reposition, they disassembled.An alternate implant was used to complete the case without reported patient impacts.This is report two of two for this event.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The complaint is confirmed.Visual examination of the returned product/provided pictures identified that when the returned pieces were fit together and confirmed that the fit was loose.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OPTIO-C, PLATE, 7MM
• Type of Device: OPTIO-C ANTERIOR CERVICAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10440497
• MDR Text Key: 204013299
• Report Number: 3012447612-2020-00453
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K141500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01873.007
• Device Lot Number: 10089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1