MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 12X14 H6MM; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number	MC1342P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Establishment name: (b)(6).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 roi-c cage broke while the surgeon was impacting the plate to complete the construct assembly in surgery.The cage and plate were removed and replaced with another cage and plate to complete the procedure.There were no reported patient impacts.
Event or Problem Description
It was reported that an roi-c cage broke while the surgeon was impacting the plate to complete the construct assembly in surgery.The cage and plate were removed and replaced with another cage and plate to complete the procedure.There were no reported patient impacts.
Additional Manufacturer Narrative
Product evaluation: visual inspection of the returned cage confirmed that the cage has fractured.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the implant was being used or handled at the time of the damage.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: ROI-C IMPLANT 12X14 H6MM
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 11158256
• Report Number: 3004788213-2020-00258
• Device Sequence Number: 19044299
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)241101(10)75250
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 11/01/2024
• Device Catalogue Number: MC1342P
• Device Lot Number: 75250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 80