MAUDE Adverse Event Report: LDR MEDICAL IMPLANT HOLDER; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB9001R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 knob of the implant holder broke off while the surgeon was attempting to remove it from the implant.There was a greater than 30 minute delay while the surgeon removed the broken implant holder.There was no additional reported patient harm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The event is confirmed with photographs received.Upon inspection, the knob is fractured off.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Additional information: d4 (lot number).
Event or Problem Description
It was reported that during the procedure, the knob of the implant holder broke off while the surgeon was attempting to remove it from the implant.There was a greater than 30 minute delay while the surgeon removed the broken implant holder.There was no additional reported patient harm.
Additional Manufacturer Narrative
Corrections in d4: udi number.Additional information in h6: component, impact, clinical, and investigation type.Visual inspection: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the knob has fractured off the device.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that during the procedure, the knob of the implant holder broke off while the surgeon was attempting to remove it from the implant.There was a greater than 30 minute delay while the surgeon removed the broken implant holder.There was no additional reported patient harm.

• Brand Name: IMPLANT HOLDER
• 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
• Manufacturer (Section G): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: florence maily ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na ; 33382803
• MDR Report Key: 9969854
• Report Number: 3004788213-2020-00045
• Device Sequence Number: 4355634
• Product Code: MJO
• UDI-Device Identifier: 03662663000741
• UDI-Public: (01)03662663000741(10)610006314/01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MB9001R
• Device Lot Number: 610006314/01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 11/03/2020; 03/30/2022
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 08/27/2020; 11/10/2020; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT#: MB2554 MOBI-C LOT#: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown