MAUDE Adverse Event Report: LDR MEDICAL IMPLANT MOBIC M ST 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3555
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	12/05/2019
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, while the surgeon was placing the implant, he hit the knob with the mallet when the peak cartridge released from the implant and the implant disassembled in the disc space.The implant was removed and an alternate of the same size was used to complete the case.There were no reported patient impacts.
Additional Manufacturer Narrative
Additional information in b4, d4: expiration date, d10: device availability, h6: methods, results, and conclusion codes.The identity of the device was inspected.The superior plate had pn: mb066k, ln: 5333012.The inferior plate had pn: mb107k, ln: 5333859.The device was examined.Visual inspection revealed no visible damage.The implant came with the all parts disassembled from the rest of the components.The implant was able to be disassembled and reassembled with ease.The implant was then tested with an inserter {outer shaft (pn: mb9001r-1, ln: 510250205/16), locking nut (pn: mb9001r-3, ln: 110085201 / 08), and inner shaft (pn: mb9001r-2, ln: 41015703/008)}.The implant was able to be fully engaged with and properly detached from the inserter.The associated inserter was disassembled and tested.The specified identity of the device was confirmed and the device was examined.Visual inspection revealed no visible damage.The outer shaft was tested with a locking nut (pn: mb9001r-3, ln: 110085201 / 08) and inner shaft (pn: mb9001r-2, ln: 41015703/008).Another mobi-c (mb3555, inferior plate mb107k, ln: 5268164 and superior plate mb0066k, ln: 5286210) was connected to the inserter assembly and disassembled by turning the knob.Everything assembled and operated as expected.The inner shaft (mb9001r-2, ln: 710173402/07) and locking nut (pn: 9001r-3, ln: 71086210/33) from the original assembly were tested with a different outer shaft (pn: mb9001r-1, ln: 510250205/16).Everything assembled and operated as expected.The demo mobi-c (mb3555, inferior plate mb107k, ln: 5268164 and superior plate mb0066k, ln: 5286210) was connected to the inserter assembly and disassembled by turning the knob.The inserter did not contribute to the event.The device history record (dhr) was reviewed.There were no nonconformances or temporary deviations associated with this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.It was reported that during the procedure, while the surgeon was placing the implant, he hit the knob with the mallet when the peak cartridge released from the implant and the implant disassembled in the disc space.The implant was removed and an alternate of the same size was used to complete the case.The reported complaint was confirmed.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The retention feature failures typically are caused by the incorrect orientation of the implant assembly and the under tightening or overtightening of the inserter.
Event or Problem Description
It was reported that during the procedure, while the surgeon was placing the implant, he hit the knob with the mallet when the peak cartridge released from the implant and the implant disassembled in the disc space.The implant was removed and an alternate of the same size was used to complete the case.There were no reported patient impacts.

• Brand Name: IMPLANT MOBIC M ST 15X15 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: 9566571
• Report Number: 3004788213-2020-00002
• Device Sequence Number: 2866326
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)240301(10)5337304
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/21/2020

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: 03/01/2024
• Device Catalogue Number: MB3555
• Device Lot Number: 5337304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR