MAUDE Adverse Event Report: AESCULAP AG ACTIV L PE-INLAY 8.5MM; ACTIV L IMPLANTS

Model Number SW965

Device Problems Defective Device (2588); Expulsion (2933)

Patient Problem Failure of Implant (1924)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported that a patient underwent a lumbar total disc replacement (tdr).Six days post-op the patient experienced expulsion which required medical intervention to remove the implanted device.It is reported the surgeon believed this was due to a pars defect that was undetected prior to the initial surgery.Additional information regarding patient outcome has been requested, however, not yet received.When additional information becomes available a follow up report will be submitted.Activl artificial disc system is composed of 3 pieces, reported as concomitant products: sw965 / activ l pe-inlay 8.5mm, sw996k / activ l inf.Plate s1 size l 5°/spikes, sw991k / activ l sup.Plate size l 6°/spikes.

Manufacturer Narrative

Investigation: no product at hand.Batch history review: the manufacturing documents for all batches have been checked and found to be according to specification valid during the time of production.There are no further complaints with this batch at hand.Conclusion and root cause: due to the circumstances we do not receive any devices for investigation and the lack of information it is not possible to determine a definitive conclusion and root cause for this failure.Rationale: because there are no products and only minor information available, a definitive root cause analysis is not possible.The following causes are possible.Incorrect system configuration selected by the user.Incorrect implant size chosen by the user.End plate formed to strongly by the user.Design layout unsuitable.Inadequate patient behaviour.No capa is necessary.

• Brand Name: ACTIV L PE-INLAY 8.5MM
• Type of Device: ACTIV L IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8236705
• MDR Text Key: 132782664
• Report Number: 9610612-2019-00008
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P120024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SW965
• Device Catalogue Number: SW965
• Device Lot Number: 52333687
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2019
• Device Age: 1 YR
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SW965 / ACTIV L PE-INLAY 8.5MM; SW991K / ACTIV L SUP.PLATE SIZE L 6°/SPIKES; SW996K / ACTIV L INF.PLATE S1 SIZE L 5°/SPIKES
• Patient Outcome(s): Required Intervention