MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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 an implant disassembled during surgery.While implanting the surgeon wanted to make an adjustment to the implant position, so he proceeded to pull the implant out.The bottom endplate and poly core stayed in the patient, but the peek cartridge and the superior endplate came out still attached to the inserter.He dug out the other two pieces and a second implant was used.There was no reported patient harm or injury.
Event or Problem Description
It was reported that an implant disassembled during surgery.During installation, the surgeon wanted to make an adjustment to the implant position so he proceeded to pull the implant out.The inferior plate and poly core remained in the disc space while the superior plate was removed with the cartridge and inserter.The inferior plate and poly core were removed from the disc space and another mobi-c was used to complete the procedure without patient impacts.
Additional Manufacturer Narrative
Corrected information in b5 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed that the screw piece has a small rust colored stain.The upper plate is labeled mb074k/5364744.The lower plate is labeled mb115k/5364610.The item could be fully disassembled and reassembled using si-mobc-0001 with no difficulty.Potential cause: root cause was unable to be determined.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.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.

• Brand Name: IMPLANT MOBIC M ST 15X17 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: 11948224
• Report Number: 3004788213-2021-00064
• Device Sequence Number: 3965597
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)250901(10)5371060
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 09/01/2025
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5371060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1