MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ARCADIUS XP L IMPLANT 9° 29X40X16MM; SIBD LUMBAR IMPLANTS

Model Number SO861P

Device Problem Break (1069)

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

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country complaints: usa.It was reported that the implant broke on impaction.

Manufacturer Narrative

Investigation: no product is at hand.Batch history review: the manfacturing documents have been checked and found to be according to the specification valid at the time of production.There are no further complaints with this lot.Conclusion and root cause: the root cause of the problem is most probably user related.Rational: because we have neither product nor a precise case description, a definite root cause analysis is not possible.Following root causes are possible.Excessive impaction force.Improper usage of the instruments.Incorrect handling of the inserter.Improper inserter assembly to implant.According to a dhr, a material defect or manufacturing error can be excluded.No capa is necessary.

• Brand Name: ARCADIUS XP L IMPLANT 9° 29X40X16MM
• Type of Device: SIBD LUMBAR IMPLANTS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7434550
• MDR Text Key: 105657618
• Report Number: 9610612-2018-00192
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2019
• Device Model Number: SO861P
• Device Catalogue Number: SO861P
• Device Lot Number: 52024080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2018
• Device Age: 4 YR
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other