MAUDE Adverse Event Report: AESCULAP AG ACTIV L TIP F/ANTERIOR MIDLINE MARKER; ACTIV L INSTRUMENTS

Model Number FW938SU

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Neuralgia (4413)

Event Date 09/02/2020

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 a fw938su - activ l tip f/anterior midline marker.According to the complaint description, the patient began to feel pain on (b)(6) 2020.It was noted that the patient experienced "right leg radiculopathy approximately one week after surgery without any incitive event.Post-op ct showed several impairment and i sent him for a selective nerve root block with relief".Further information: occurred during surgery: no.Occurred during inspection: no.Identified in spd or routine maintenance: no.Type of indication / operation: artificial disc replacement.Patient injury: no.Hazard / patient harm: no.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4) ((b)(4)).Associated medwatch-reports: 9610612-2020-00648 ((b)(4)), 9610612-2020-00646 ((b)(4)), 9610612-2020-00647 ((b)(4)).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00648 (400486284 + sw965).9610612-2020-00646 (400486282 + sw981k).9610612-2020-00647 (400486283 + sw986k).Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.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 are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.

• Brand Name: ACTIV L TIP F/ANTERIOR MIDLINE MARKER
• Type of Device: ACTIV L INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10719234
• MDR Text Key: 216611537
• Report Number: 9610612-2020-00645
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: A883011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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: 11/30/2023
• Device Model Number: FW938SU
• Device Catalogue Number: FW938SU
• Device Lot Number: 52483874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 75