MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 14X15,5 H4,5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 a piece of roi-c cage broke off while anchoring plates were being hammered into the cage.The cage was removed and replaced.There was no reported patient harm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Corrected information in h3.Added information to h6: component codes, type of investigation, investigation findings, investigation conclusions.Summary: the complaint is confirmed for the returned roi-c cage (pn: mc1320p) for the failure of cage broke during operation.Visual inspection confirms the cage was fractured.Medical records were not provided for review.Potential cause: root cause was unable to be determined with the given information.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.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a piece of roi-c cage broke off while anchoring plates were being hammered into the cage.The cage was removed and replaced.There was no reported patient harm.

• Brand Name: IMPLANT ROI-C 14X15,5 H4,5
• 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, n/a 10300 ; FR 10300
• MDR Report Key: 11268011
• Report Number: 3004788213-2021-00006
• Device Sequence Number: 13744367
• Product Code: ODP
• UDI-Device Identifier: 03662663016124
• UDI-Public: (01)03662663016124(17)220101(10)23228R260
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/11/2021

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: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MC1320P
• Device Lot Number: 23228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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