• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM SOLID SPINE SURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM SOLID SPINE SURGERY Back to Search Results
Model Number SY135TS
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
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 sy135ts - ennovate polyax. Screw 6. 5x50mm solid. During the surgery, the screw was found to be not fully seated on driver and scrub technician could not back the screw off. A second screw was opened and the backup driver was utilized to avoid delaying the procedure. The affected screw and driver were removed from the sterile field and the aesculap representative was able to separate the two. The driver seemed fine, but the screw was observed to possibly be cross-threaded. There was no described patient harm. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENNOVATE POLYAX.SCREW 6.5X50MM SOLID
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 Key12489104
MDR Text Key271936036
Report Number9610612-2021-00612
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04046964989209
UDI-Public4046964989209
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180433
Number of Events Reported1
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 09/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY135TS
Device Catalogue NumberSY135TS
Device Lot Number52679891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-