MAUDE Adverse Event Report: LDR MEDICAL IMPLANT MOBIC M ST 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3355
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	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that during the procedure the implant disassembled in the disc space.The implant was removed and an alternate implant of the same size was used to complete the case.There were no additional patient impacts or surgical delays reported.
Event or Problem Description
It was reported that during the procedure the implant disassembled in the disc space.The implant was removed and an alternate implant of the same size was used to complete the case.There were no additional patient impacts or surgical delays reported.
Additional Manufacturer Narrative
The complaint is non-verifiable for one (1) of one (1) returned mobi-c implant (pn mb3355) for the failure of disassembly when removing the peek from the implant.The severity of this event is 0 (rmr-00107).Medical records were not provided for review.Potential cause: this failure could be caused by failure to widen the peek cartridge enough to clear the side posts of the prosthesis plates during removal, and/or failure to rotate the peek to the correct angle during removal, causing it to bind/stick on the prosthesis, leading to disassembly.Complaint history: there were other 8 complaints for similar events related to the same part number in the 12 months leading up to the notification date through to the present.There were zero (0) other complaints related to this lot number in 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 or 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: IMPLANT MOBIC M ST 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 9206009
• Report Number: 3004788213-2019-00301
• Device Sequence Number: 10839107
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)230601(10)5317489
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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: 06/01/2023
• Device Catalogue Number: MB3355
• Device Lot Number: 5317489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/17/2019
• 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
• Patient Weight: 65