MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problem Break (1069)

Patient Problems Pain (1994); Discomfort (2330); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.The review of the device history records and traceability can't be reviewed as reference and lot number of involved product are unknown, device manufacturing date is also unknown.No x-rays or any additional information were provided at this time.Investigation is still in progress.Conclusion is not yet available.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr: product still implanted.

Event Description

Roi-a: broken anchoring plate 6 weeks post op.It was reported a breakage of roi-a upper anchoring plate was detected at 6 weeks post-op.No other information provided as reference of product, lot number, x-rays, initial surgery date.Additional information was requested and is pending.

Event Description

Roi-a : broken anchoring plate 6 weeks post op it was reported a breakage of roi-a upper anchoring plate was detected at 6 weeks post-op.Additional informations were received on april 8th , allows to to identify the reference and lot number of the anchoring plate.In addition , post-op x-rays were provided which confirm a vertebral body fusion at l5 / s1, and breakage of the inferior plate not the superior as previously reported.According to the reporter the original indication related to the surgery was a degenerative segment disease l5/s1 with significant sintering of the intervertebral space.In addition , there wasn¿t a trauma or shock who can explain the post-op breakage.Patient is suffering from pain and difficulty to move.According to the available information , no revision surgery is scheduled for this case.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information : without a product return, no product evaluation is able to be conducted.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Complaint was initiated by patient husband.Additional informations were provided on april 2019 : the first indication was a degenerative segment disease l5/s1 with significant sintering of the inter-vertebral disc.Also , according to the reporter , there wasn¿t a trauma or shock who can explain the post-op breakage.It was requested from the reporter to provide additional informations from the surgeon who performed the procedure.However , according to the reporter , the surgeon will not accept to respond to additional requests.The review of this case with the product range manager, based on the device history records and traceability , the investigation found no evidence on a device issue that may have caused this event.Due to the lack of provided inputs and the absence of device examination as it's still implanted , the exact root cause of this event remain undetermined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ROI-A ANCHORING PLATE M
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8469985
• MDR Text Key: 140504614
• Report Number: 3004788213-2019-00105
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: N/A
• Device Catalogue Number: IR2008T
• Device Lot Number: 613969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 63