MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PL : 2730 H 14 MM 6; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Product is not returned yet to the manufacturer.The review of the traceability and the device history records did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.Additional information were requested.Conclusion is not available yet.Investigation still in progress.Device not received yet by manufacturer.

Event Description

Roi-a : broken cage when impacting anchoring plates.As reported in the complaint form : it was a two level surgery.The patient had previous surgery with posterior fixation l4-s1 (not ldr product) with tlif cages (not ldr product).Posterior pedicle screw fixation had been removed during an earlier revision surgery.For the surgery that happened on (b)(6) it was a revision.The reasons for the revision were non-union and migrated peek cage at l4-l5 and adjacent segment degeneration l3-l4.After removal of plif peek cage, a roi-a cage was placed uneventful in l4-l5.Then, a roi-a cage was place in l3-l4: during the impaction of the first anchoring plate in the inferior vertebrae, the peek cage broke (x-ray showed no interference of the anchoring plates with the cage in l4-l5.Cage and anchoring plate were removed.A new roi-a cage was placed using the same anchoring plate (judged intact by surgeon).There was no difficulties to deploy the anchoring plate.No harm to the patient, but delay of 10 minutes of surgery.The patient bone quality was considered normal , so , the starter awl was not used.During the broken cage insertion , there might have been a slight off axis implantation.According the reporter , the surgical technique was followed for impaction sequence.No broken cage part implanted in the patient.Product will be returned.Additional information were requested to the reporter.

Manufacturer Narrative

This medwatch is submitted following the reception of an additional information.Product was received by manufacturer.Examination of product is in process.The review of the traceability and device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The instrument and the cage were inspected by the distributor upon return of the set from hospital.The instrument was intact.The distributor cage examination mentioned that probable root cause could be related to user error as the surgeon may have inserted two anchoring plates in the same slot ( this hypothesis will be evaluated after cage examination by manufacturer).Attempts have been made to collect more information on the event and no further information has been provided.Conclusion is not available yet.Investigation still in progress.

Manufacturer Narrative

Field date of report , pma/510k; if follow-up, what type, were updated for this report ; the review of the traceability and device history records of the alleged products did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The instrument was inspected upon return of the set from hospital by the distributor.The instrument was intact.Attempts have been made to collect more information on the event and on the instrument inspection steps , no further information has been provided.The anchor was not received by the manufacturer as it's still implanted , it was judged intact by the manufacturer.The cage was received and exanimated by the manufacturer.The breakage is near the cage slot and reflect a mishandling during insertion ; according to the provided description , the returned product analysis and the recurrence of this type of issue related to this product range , the investigation found no evidence to a product issue.The root cause is related to mishandling during cage implantation.From description provided by the reporter , the cage insertion was off-axis.As mentioned in the surgical technique " make sure that cage placement is done perfectly in the axis of the intervertebral space ".Investigation found no evidence of a product issue; root cause : related to mishandling during cage implantation.

Event Description

Roi-a : broken cage when impacting anchor.

• Brand Name: ROI-A MEDIAN IMPLANT PL : 2730 H 14 MM 6
• 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: 7524906
• MDR Text Key: 108610340
• Report Number: 3004788213-2018-00161
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: N/A
• Device Catalogue Number: IR2526P
• Device Lot Number: 112737000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 53 YR