MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H11MM 27X30MM 10; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

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.No product hold was initiated.Traceability of lot # 12-283348 shows all remaining expired products were isolated in ldr medical inventory and are not available.A letter will be sent to customer to inform him on the risk for patient.Other expired products were identified in this hospital.Customer dept.Sent another reminder to the customer on (b)(4) 2017.Hospital responded that information was taken into account.On (b)(6) 2018, hospital said surgeon was informed on (b)(4) 2017, an inventory was done and expired products were isolated.Device remains implanted.

Event Description

Roi-a : expired product implanted.Information received by customer department that an implant with expired date was used and implanted at chu martinique.Customer have not communicated on this event.Customer has been informed in (b)(4) 2017 by customer dept.That implant was almost expired.In (b)(6) 2017, the hospital responded that information was taken into account and actions would be done accordingly.Moreover, customer dept.Sent another implant to replace the expired one.Implant was not returned to ldr medical and was used in surgery on (b)(6) 2017 despite the customer dept.Email.Expiration date is indicated on product (external and internal labels) and warnings are in roi-a ifu.Information was made by ldr medical to inform customer of its use of expired product.Hospital said surgeon was informed on (b)(4) 2017.Additional information requested (especially patient state of health).Waiting for an answer.

Manufacturer Narrative

After reception of this issue, a letter was sent to the hospital to inform them about the event risks, a specific patient follow-up and the probable necessity of a revision if necessary.No feed back was received.After several attempts, no information on patient state of health received nor communication about a revision.Regarding information provided, root cause is related to an user error.Implant was used in surgery despite several communication was made by the commercial team to the hospital, expiration date indicated on product and indication in roi-a ifu.The investigation found no evidence of a product issue.

Event Description

Roi-a : expired product implanted.

• Brand Name: ROI-A CAG MED H11MM 27X30MM 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: 7199182
• MDR Text Key: 97503746
• Report Number: 3004788213-2018-00015
• 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
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: N/A
• Device Catalogue Number: IR2531P
• Device Lot Number: 12-283348
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other