MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 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	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed for one (1) of one (1) returned mobi-c implant 13x15 h5 (pn mb3355) for the failure of disassembly.The severity of this event is 2 ([rmr-00107).Medical records were not provided for review.Device evaluation: the item matches information in the complaint file.The superior plate is labeled mb062k/5346307.The inferior plate is labeled mb103k/5345315.There are no visual deformities on any of the returned items.The peek cartridge and threaded screw were not returned with the mobi-c device, so the product could not be reassembled in a functional test.Complaint history: there were 5 (five) other complaints for similar events (disassembly) related to the same part number in the 12 months leading up to the notification date through to the present.0(zero) additional search results for the lot and item search.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.Potential cause: this event could possibly be attributed to, surgeon failing to disengage the implant from implant holder completely before removing the implant holder.Corrective/preventive action: no corrective or preventive actions are recommended at this time.
Event or Problem Description
It was reported that during the surgery, the mobi-c implant did not fully disengage from the implant holder, and it disassembled when it was pulled out of the disc space with the inserter.A new implant was used to successfully complete the case.There were no impacts on the patient.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 10744297
• Report Number: 3004788213-2020-00179
• Device Sequence Number: 3313186
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)241001(10)5351175
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• 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
• Report Date (Section B): 10/27/2020

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: 10/01/2024
• Device Catalogue Number: MB3355
• Device Lot Number: 5351175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR