MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE S1 SIZE L 5/SPIKES; SPINE SURGERY

Model Number SW996K

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with activ l inf.Plate s1 size.According to the customer description: "a (b)(6) year old male weighing (b)(6) kg had a removal of activl artificial disc and replaced with 360 fusion".The original implantation had been performed on (b)(6) 2019.A revision surgery was necessary.Additional information was requested.The adverse event is filed under (b)(4).Associated medwatch-reports: 9610612-2020-00059 ((b)(4) sw992k).9610612-2020-00060 ((b)(4) sw966).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00059; 9610612-2020-00060 (400464266 sw966); 9610612-2020-00061 (400464267 sw996k).Investigation results: up to now there is no product available for analysis.Batch history review: because the batch numbers are unknown up to now, a batch history review is not possible at this time.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.Following causes are possible: wrong system configuration selected by the user, wrong implant size chosen by the user, end plate formed too strong by the user, design layout unsuitable, inadequate patient behaviour.No capa required.

• Brand Name: ACTIV L INF.PLATE S1 SIZE L 5/SPIKES
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9787212
• MDR Text Key: 182309057
• Report Number: 9610612-2020-00061
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW996K
• Device Catalogue Number: SW996K
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 75