MAUDE Adverse Event Report: AESCULAP AG ACTIV L SUP.PLATE SIZE S 6/SPIKES; IMPLANTS SPINAL MOTION

Model Number SW971K

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 04/30/2020

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 product activ l pe-inlay 8.5mm.The initial implant surgery occurred on (b)(6) 2020.According to complaint description it was reported that activel implant migrated anteriorly and was removed and replaced with a fusion implant without incident on (b)(6) 2020.Unknown when implant migrated.A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00165 ((b)(4) product: sw974k), 9610612-2020-00166 ((b)(4) product: sw977k), 9610612-2020-00167 ((b)(4) product: sw965).

Manufacturer Narrative

The adverse event is filed under aag reference 100025496.Associated medwatch-reports: 9610612-2020-00165 (400471600 product: sw974k); 9610612-2020-00166 (400471601 product: sw977k); 9610612-2020-00167 (400471602 product: sw965).Manufacturing site evaluation: failure description: no product at hand.Investigation: no product at hand.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown up to now.Conclusion and root cause: due to the circumstance that we did 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; design layout unsuitable; inadequate patient behavior; maybe implant not in the correct position; not the correct system for the purpose.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

Event Description

No updates.

Manufacturer Narrative

The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 2916714-2020-00164, 2916714-2020-00161, 2916714-2020-00163.Material numbers were updated to sw965, sw976k and sw971k.Updates: d1-4.

Event Description

No updates.

Manufacturer Narrative

The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 2916714-2020-00164, 2916714-2020-00161, 2916714-2020-00163.Reference code (b)(4), device name activ l sup.Plate size s 6°/spikes, serial number n/a, batch number 52508204, udi device identifier n/a, udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di n/a, manufacturing date 13.03.2019.Reference code sw976k, device name activ l inf.Plate s1 size s 5°/spikes, serial number n/a, batch number 52479347, udi device identifier n/a, udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di n/a, manufacturing date 21.11.2018.Reference code sw965, device name activ l pe-inlay 8.5mm, serial number n/a, batch number unknown, udi device identifier n/a, udi production identifier unknown, basic udi-di n/a, unit of use udi-di n/a, manufacturing date unknown.The devices were evaluated by a third party, exponent.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There is one similar complaint against the same lot number (sw976k/52479347).Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible (sw965).Explanation and 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, design layout unsuitable, inadequate patient behavior, maybe implant not in the correct position (as shown on x-ray), not the correct system for the purpose.The external investigation at "exponent" did not reveal any product deviations.A material defect or manufacturing error can be excluded.Conclusion and root cause: due to the current deviation and according to the rationale, the root cause of the problem is most probably patient or usage-related.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

Event Description

No updates.

• Brand Name: ACTIV L SUP.PLATE SIZE S 6/SPIKES
• Type of Device: IMPLANTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10078972
• MDR Text Key: 199684630
• Report Number: 2916714-2020-00161
• 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,Followup
• Report Date: 09/10/2020

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 Expiration Date: 03/12/2024
• Device Model Number: SW971K
• Device Catalogue Number: SW971K
• Device Lot Number: 52508204
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2020; 08/24/2020; 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 67