MAUDE Adverse Event Report: AESCULAP AG S4 POLYAXIAL SCREW 6.5X50MM CANULATED; SPINE SURGERY

Model Number SW347T

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

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 sw347t - s4 polyaxial screw 6.5x50mm canulated.According to the complaint description, the s4 extension surgery, a docter closed the wound without fold and remove the screw tab.At that time x-ray confirmation, the image of the tab part was unclear, so it was considered that the fixation was good.After that, when the x-ray was shaded and reconfirmed, it was discovered that he forgot to fold the tab and remove it.One hour later, the surgery was re-operated and the tab was folded to complete.The final implant was successfully fixed.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00815 (b)(4).

Manufacturer Narrative

Associated medwatches: 9610612-2020-00815, 9610612-2020-00814.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / 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 investigations results a capa is not necessary.

• Brand Name: S4 POLYAXIAL SCREW 6.5X50MM CANULATED
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10792770
• MDR Text Key: 214798830
• Report Number: 9610612-2020-00814
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K071945
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW347T
• Device Catalogue Number: SW347T
• Device Lot Number: 51990713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other