MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 12X14 H6MM; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATION FIXATION, CERVICAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was returned without decontamination form which prevent it's examination.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.As indicated into roi-c surgical technique : at step: insertion of the second half anchoring plate: insert the second half anchoring plate and impact it by following the same technique that the one used for the first half anchoring plate, while ensuring to insert this second half anchoring plate into the slot at the opposite of the one used for the first half anchoring plate.From the information provided, the product history records, the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.The root cause is related to a mishandling during anchoring plate impaction : the two anchoring plates were inserted in the same slot of inserter and it breaks the cage.
Event or Problem Description
Roi-c: broken cage during implantation.It was reported that during a roi-c surgery the cage broke when it was implanted.The surgery was completed with another product.The patient is in good health.The procedure was delayed for nearly 30 minutes due to the need to remove the damaged cage when the event occurred.The patient had normal bone mass.The connection between cage and cage holder was correct.The sagittal angle was respecting head or foot direction.The impact sequence of anchor plate respects the surgical technique (first using impactor 1, then using impactor 2).The first anchor plate was fully in place but the two anchors were implanted in the same slot.No x-rays are available.
Event or Problem Description
Roi-c: broken cage during implantation.It was reported that during a roi-c surgery the cage broke when it was implanted.The surgery was completed with another product.The patient is in good health.The procedure was delayed for nearly 30 minutes due to the need to remove the damaged cage when the event occurred.The patient had normal bone mass.The connection between cage and cage holder was corret.The sagittal angle was respecting head or foot direction.The impact sequence of anchor plate respects the surgical technique (first using impactor 1, then using impactor 2) the first anchor plate was fully in place but the two anchors were implanted in the same slot.No x-rays are available.
Additional Manufacturer Narrative
Product was not returned to zimmer biomet colorado, however, pictures of the device were provided.The images confirm that the cage fractured on the end where the plates are inserted.The complaint is confirmed for fracture.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The fracture likely occurs due to the plate applying force on the strut that is on the anterior side of the groove.The force can come from the plate entering hard bone and bending from the resistance, from the cage moving posteriorly after the plate has been partially or totally inserted, or from the first plate not being fully inserted or some other obstruction in the groove.

• Brand Name: ROI-C IMPLANT 12X14 H6MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATION FIXATION, CERVICAL
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8572609
• Report Number: 3004788213-2019-00131
• Device Sequence Number: 2211826
• Product Code: OVE
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)230601(10)66193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 06/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MC1342P
• Device Lot Number: 66193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/29/2020
• 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 Age: 48 YR