MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE SIZE L 0°/SPIKES; SPINE SURGERY

Model Number SW990K

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2022

Event Type  Injury  

Event Description

Doit was reported that there was an issue with sw990k - activ l inf.Plate size l 0°/spikes.According to the complaint description, the implant migrated anteriorly post-operative.A revision surgery was performed to re-position the implant.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: (b)(4) (9610612-2022-00352) - sw991k, (b)(4) (9610612-2022-00353) - sw965, (b)(4) (9610612-2022-00354) - sw990k.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Investigation was based on review of device history records.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are currently four further complaints with this lot at hand.The assessment for the adverse event is based on patient harm, revision.Conclusion/preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

Event Description

Associated medwatch-reports: 400575747 (9610612-2022-00352) - sw991k.400576631 (9610612-2022-00353) - sw965.400576632 (9610612-2022-00354) - sw990k.

• Brand Name: ACTIV L INF.PLATE SIZE L 0°/SPIKES
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15809552
• MDR Text Key: 303800032
• Report Number: 9610612-2022-00354
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW990K
• Device Catalogue Number: SW990K
• Device Lot Number: 52743008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male