MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 12X14 H6; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference report 3004788213-2021-00055.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 upon placing the implant and plate into the disc space, they broke.The surgeon removed them and used new devices to complete the surgery.No debris was created.There was no reported delay of surgery or harm to the patient.This is report one of two for this event.
Additional Manufacturer Narrative
Device evaluation: photos were provided showing the plate and cage fracture.Potential cause root cause was unable to be determined.This event could possibly be attributed to incomplete threading of the cage and angulation of the holder, not respecting impaction sequences, positioning two anchoring plates into the same slot by incorrect loading, or the anchoring plate hitting distraction pins, plate screws or hard bone.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.
Event or Problem Description
It was reported that upon placing the implant and plate into the disc space, they broke.The surgeon removed them and used new devices to complete the surgery.No debris was created.There was no reported delay of surgery or harm to the patient.This is report one of two for this event.

• Brand Name: IMPLANT ROI-C 12X14 H6
• 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: 11871439
• Report Number: 3004788213-2021-00054
• Device Sequence Number: 3179223
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)240901(10)73681
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 09/01/2024
• Device Model Number: N/A
• Device Catalogue Number: MC1342P
• Device Lot Number: 73681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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
• Patient Weight: 56