MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE S1 SIZE S 5/SPIKES; PREVIOUSLY REPORTED

Model Number SW976K

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

When additional information is received a follow up report will be submitted.

Event Description

It was reported that there was an issue with an activl implant system.The reporter indicated that 3 weeks post-operatively (initial surgery (b)(6) 2019) an explant kit was ordered and a revision surgery took place on (b)(6) 2019 due to implant migration.The surgeon found two fractures on s1 that may have led to "spit out".It was also noted that the patient might also have had bone quality issues.Additional information reported that it was determined that the patients s1 vertebra was fractured creating an unstable platform.Activl was explanted and a fusion was conducted.Per follow up with the surgeon, one-week post-op the patient was doing well.Associated medwatches: 2916714-2020-00002, 2916714-2019-00138.

Manufacturer Narrative

Associated medwatches: 9610212-2019-00844 (b)(4).9610612-2019-00893 (b)(4) for this case is the report.9610612-2019-00894 (b)(4).General information: post operataive incident.Up to now there is no product available for analysis.Investigation: no product at hand.Batch history review: the manufacturing documents of each lot have been checked and found to be according to specification valid during the time of production.There is one further complaints with lot 52443910 (sw971k) at hand.Conclusion and root cause: the root cause for the problem is most probable usage and/or patient related.Rationale: because there are no products and only minor information available, a definitive root cause analysis is not possible.Following causes are possible: inadequate bone quality, wrong system configuration selected by the user, wrong implant size choosen by the user, end plate formed to strong by the user, design layout unsuitable, the suspicion of inadequate bone quality was mentioned in the complaint.Corrective action: according to (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

No update provided.

Event Description

No updated provided.

Manufacturer Narrative

Investigation by third party performed, and found no deviations.Aesculap ag reviewed and approved the investigation by exponent.Associated medwatches: 9610212-2019-00844 (400455858 sw971k) ; 9610612-2019-00893 (400457416 sw976k) ; 9610612-2019-00894 (400457417 sw965).General information: post operataive incident.Up to now there is no product available for analysis.Investigation: no product at hand.Batch history review: the manufacturing documents of each lot have been checked and found to be according to specification valid during the time of production.There is one further complaints with lot 52443910 (sw971k) at hand.Conclusion and root cause: the root cause for the problem is most probable usage and/or patient related.Rationale: because there are no products and only minor information available, a definitive root cause analysis is not possible.Following causes are possible: inadequate bone quality, wrong system configuration selected by the user, wrong implant size choosen by the user, end plate formed to strong by the user design layout unsuitable, the suspicion of inadequate bone quality was mentioned in the complaint.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: ACTIV L INF.PLATE S1 SIZE S 5/SPIKES
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9547591
• MDR Text Key: 173901641
• Report Number: 2916714-2020-00001
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW976K
• Device Catalogue Number: SW976K
• Device Lot Number: 52479347
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/19/2020; 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 54