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

Catalog Number	07.01873.007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that during the procedure the plate disassembled.It was removed and replaced with a same sized plate to complete the case.There was no reported patient harm.
Event or Problem Description
It was reported that during the procedure the plate disassembled.It was removed and replaced with a same sized plate to complete the case.There was no reported patient harm.
Additional Manufacturer Narrative
The complaint is confirmed for one (1) of one (1) returned optio-c 7mm plate (pn 07.01873.007) for the failure of bent retention feature causing mating issue as determined through visual and functional inspection.Medical records were not provided for review.Potential cause root cause was unable to be determined with the given information.This event could possibly be attributed to a force capable of overcoming the material properties of the retention feature either during the attempt to place the plate and interbody together.Complaint history: no capa¿s, ie, pa¿s are attached to any of the identified complaints.Review of complaint history for the part identified 1 additional complaint(s) for the same or similar issue in the 12 months leading up to the complaint through to the date the report ran (b)(6) 2020.Additionally, 0 total other complaints were found for ln 10141 for all time.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions, recalls or product holds.Device use and compatibility this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.

• Brand Name: OPTIO-C, PLATE, 7MM
• Common Device Name: OPTIO-C ANTERIOR CERVICAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10359869
• Report Number: 3012447612-2020-00398
• Device Sequence Number: 2329710
• Product Code: KWQ
• UDI-Device Identifier: 00889024329607
• UDI-Public: (01)00889024329607(17)240516(10)10141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2024
• Device Catalogue Number: 07.01873.007
• Device Lot Number: 10141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1