MAUDE Adverse Event Report: AESCULAP AG ARCADIUS XP L IMPLANT 9° 29X40X14MM; IMPLANTS INTERBODY FUSION

Model Number SO859P

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported there was an intraoperative issue with an arcadius cage.On (b)(6) 2019, the patient underwent an anterior lumber interbody fusion (alif) and an arcadius cage was used.While attempting insertion of a medial screw, the cage broke.A self-centering awl and flexible driver had been used.The surgeon was noted to have to redo a key step in the procedure and there was a 30-45 minute delay.Additional details on the key step were not provided.An x-ray was not required.Further information was requested.Concomitant devices: medial screw (part # unknown, lot # unknown, quantity 1); self-centering flexible awl (part # unknown, lot # unknown, quantity 1); flexible driver (part # unknown, lot # unknown, quantity 1).

Manufacturer Narrative

Manufacturing site evaluation: investigation: no product at hand, nor pictures provided.Batch history review: the manufacturing documents have been checked and found to be according to specifications valid during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause: the root cause for the problem is most likely usage related.Rationale: in similar cases as described in the complaint, through a damaged thread and the squeezed material it produced inner tensions.Those tensions led to cracks and chipped off material/edges.The damage of the thread of the implant could have perhaps been caused through the following: the implant screws were cross-threaded.The bone was not properly prepared.According to the quality standard and batch history files, a material defect or production error can be excluded.There are no hints of a pre-damage or similar issue.A capa was opened.

• Brand Name: ARCADIUS XP L IMPLANT 9° 29X40X14MM
• Type of Device: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8504753
• MDR Text Key: 141621981
• Report Number: 9610612-2019-00248
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K111122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: SO859P
• Device Catalogue Number: SO859P
• Device Lot Number: 52423773
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/24/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXIBLE DRIVER; MEDIAL SCREW; SELF-CENTERING FLEXIBLE AWL; FLEXIBLE DRIVER; MEDIAL SCREW; SELF-CENTERING FLEXIBLE AWL
• Patient Outcome(s): Required Intervention