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

Model Number N/A

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

The product was not returned to ldr medical.No visual and functional evaluation can be performed.The product is still implanted in the patient.The review of the device history records and traceability cannot be performed because the reference and the lot number were not provided.Attempts to obtain more information have been made but without response yet.Investigation still in progress.Conclusion not yet available.Device still implanted.

Event Description

Roi-a : broken cage during impaction of anchoring plate.According to the reporter: after the implant was in the disc space at l5-s1 the inserter came loose before the upper blade was fully impacted.It was seen after the inserter was removed that a small piece of the peek was broken off which was located and removed.The upper blade was not locked in, the surgeon secondary impacted it in but the angle prevented from him from getting it locked because the patient pelvic incidence was so high (sacrum was almost horizontal).It was suggested to start with a new implant but the surgeon was unable to get the blade out due to the patient angle.He was also unable to drill off the peek to remove the blade due to the patient angle.The surgeon backed up the patient posteriorly with screws and felt this would suffice.It is believed that due to the patient anatomy, the inserter was being forced at an angle that caused the peek to break.Delay 15 min.Additional information from october, 4th, 2018: classic implant holder has been used during the surgery.Cage was properly assembled and double checked for toggle before insertion tightening was done without the locking key per the technique guide to not strip the peek.Starter awl was not used.The adjustable stop was not used.Pre-op, per-op and post-op images are not available.The issue occurred for implantation of the first anchoring plate.Attempts to obtain more information about the bones of the patient have been made.No response yet.

Event Description

Roi-a : broken cage during impaction of anchoring plate.Acording to the reporter: after the implant was in the disc space at l5-s1 the inserter came loose before the upper blade was fully impacted.It was seen after the inserter was removed that a small piece of the peek was broken off which was located and removed.The upper blade was not locked in, the surgeon secondary impacted it in but the angle prevented from him from getting it locked because the patient pelvic incidence was so high (sacrum was almost horizontal).It was suggested to start with a new implant but the surgeon was unable to get the blade out due to the patient angle.He was also unable to drill off the peek to remove the blade due to the patient angle.The surgeon backed up the patient posteriorly with screws and felt this would suffice.It is believed that due to the patient anatomy, the inserter was being forced at an angle that caused the peek to break.Delay 15 min.Additional information from october, 4th, 2018: -classic implant holder has been used during the surgery.-cage was properly assembled and double checked for toggle before insertion -tightening was done without the locking key per the technique guide to not strip the peek -starter awl was not used -the adjustable stop was not used.-pre-op, per-op and post-op images are not available.-the issue occurred for implantation of the first anchoring plate.Additional information from (b)(6), 2018: the patient bones was very hard.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.The product was not returned to ldr medical.No visual and functionnal evaluation can be performed.The product was still implanted in the patient.The review of the device history records and the traceability was not possible as the device reference and lot number were not provided.From information provided by the reporter, based on the product history records, the review of the case and the recurrence of this type of event for this implant, the likely cause for the event is a user error due to the non-use of the starter awl instead of the patient's bones was very hard.The use of the statrter awl when the bones are hard or very hard is indicated in the surgical technique of a roi a products.The investigation found no evidence to indicate device issue.The root cause is user error.

• Brand Name: ANCHORING PLATE ROI-A
• 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: 8008125
• MDR Text Key: 125097525
• Report Number: 3004788213-2018-00354
• 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
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NO INFORMATION
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1