MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT H12MM 30X33MM 10; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.The 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.It was reported that the product will be returned to the manufacturer for evaluation.It has not been received yet.Upon return of the product, the product evaluation will be performed.Investigation is still in progress.Conclusion not yet available.Device has not been returned yet.

Event Description

Roi-a : broken cage during impaction of cage or anchoring plate.(b)(6) reported that a patient of (b)(6) years, during anterior surgery l5-s1 with roi-a cage, the implant broke during impaction of the cage into space or during impaction of anchoring plate in l5 / s1 which could have damaged the cage.The implants were removed and a new implant was inserted.The surgery was delayed about 15 minutes with an increased hemorrhagic risk.No harm to the patient.It was also reported by reporter on (b)(6) 2019: the patient's bones are normal.The roi-a sterile starter awl for anchoring plate was not used.The lockable adjustable stop was used.A parallel distraction was performed.An anterior surgery was performed.During the impaction of the first anchoring plate, it was inserted in the upper slot of the cage.Only the short anchoring plate impactor was used, the second anchoring plate impactor was not used.It is not possible to know when the cage broke whether or not it was during the impaction of the first or second anchoring plate as it was diagnosed at the implant holder ablation.No pre- and per-op x-ray images are available.A lumbar spine scanner was performed post-operatively, concluding in a good position of the intersomatic cage.Waiting for product return.

Manufacturer Narrative

The products were returned to the manufacturer on february 25th 2019.Yet, the decontamination form received on february 26th 2019 stated that the disinfection/cleaning was not performed.The device was received in condition making evaluation impossible.From the information provided, the product history records, the review of the case and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, it could be hypothesized that the implant underwent a preoperative damage not revealed, causing its break.However, without the product evaluation, this hypothesis cannot be validated.The root cause of the reported event remains undetermined with the most likely hypothesis of user error.If additional information is received that allows to draw a conclusion, this case will be reopened and the root cause of the complaint will be reevaluated.

Event Description

Roi-a : broken cage during impaction of cage or anchoring plate.The products were returned to the manufacturer on february 25th 2019.Yet, the decontamination form received on february 26th 2019 stated that the disinfection/cleaning was not performed.The device was received in condition making evaluation impossible.

• Brand Name: ROI-A MEDIAN IMPLANT H12MM 30X33MM 10
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8325022
• MDR Text Key: 135693539
• Report Number: 3004788213-2019-00023
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR2632P
• Device Lot Number: M42582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 81