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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.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.Product remain implanted and no revision is scheduled yet.Investigation is still in progress.Conclusion not yet available.Not returned to manufacturer.

Event Description

Roi-a: anchoring plate broken post-op.(b)(4) (distributor) reported that the distal roi-a blade fractured in sacrum.It was found on follow-up xray.Initial surgery was in (b)(6) 2018 and broke during 2018 year.The exact event date was not communicated.Additional information received on december 26th 2018: the patient is getting ct scan.A revision has not been planned yet.It is not possible to get the surgical report of initial surgery or to have information about the initial surgery.No trauma occured.The patient is not a smoker.Additional informations requested and not received yet.

Event Description

Roi-a : anchoring plate broken post-op.According to the reporter : the distal roi-a anchoring plate fractured in sacrum.It was found on follow-up xray on (b)(6) 2018.Initial surgery was in (b)(6) 2018 and broke during 2018 year.Product is still implanted.Additional information received on december 26th 2018: the patient is getting ct scan.A revision has not been planned.It is not possible to get the surgical report of initial surgery or to have information about the initial surgery.No trauma occured.The patient is not a smoker.Additional information received on january 17th 2019: the patient's indication is ddd l5-s1.There was no damage on the cage during its impaction.The provided inserter was used for impaction.No tamping occured after placement.Additional information received on january 21st 2019: the patient is still awaiting ct scan.No revision has been scheduled.The surgical technique was followed according to the reporter.The sterile starter awl was not used during the initial surgery.The patient's bones were unremarkable.Additional information received on january 23rd 2019: the cage was positioned median.The lockable adjustable stop was used.Parallel distraction was not performed.The short anchoring plate impactor was used before the second anchoring plate impactor.The inferior anchoring plate was placed first.There was no surgical difference between the insertion of the first and second anchoring plates.The anchoring plates reached the mechanical stop on the implant holder.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint following the additional information received.Product remains implanted and no revision has been scheduled.Therefore, no product evaluation could be performed.From the information provided based on the zper, the product history records, the review of the case with the product manager and the recurrence of this type of event for this product, the root cause of the event cannot be determined.However it could be hypothesized that the patient was not cautious prior to the implant fusion, which could have caused the anchoring plate break.The surgeon should have advised the patient, especially concerning his mobility.It is clearly stated in the instructions for use that the risks associated with general surgery, orthopedic surgery, and the use of general anesthesia should be explained to the patient prior to surgery.It is also recommended that the advantages and disadvantages of surgery, the implants, as well as alternative treatment methods be explained to the patient.However, without the product return and evaluation, this hypothesis cannot be validated.The investigation found no evidence to indicate a device issue.The root cause 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, the root cause of the complaint will be reevaluated and a medwatch follow-up report will be sent.

• 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: 8225482
• MDR Text Key: 132342134
• Report Number: 3004788213-2019-00008
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR2008T
• Device Lot Number: 282617/4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR