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U.S. Department of Health and Human Services

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

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AESCULAP AG S4 POLYAXIAL SCREW 6.5X50MM CANULATED SPINE SURGERY Back to Search Results
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 doctor 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 is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00814 (b)(4).
 
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Brand NameS4 POLYAXIAL SCREW 6.5X50MM CANULATED
Type of DeviceSPINE 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 grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10792767
MDR Text Key214798875
Report Number9610612-2020-00815
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071945
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
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 Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSW347T
Device Catalogue NumberSW347T
Device Lot Number52359750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/05/2020 Patient Sequence Number: 1
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