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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657334S
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  Malfunction  
Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

 
Event Description

"it was reported that during surgery the nurse found the foreign material in the sterile pack for this item when they open the packaging. The foreign material was 4mm cubic, was seemed a rubber. The new screw was used for the surgery and it was successful. ".

 
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Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11121280
MDR Text Key227976607
Report Number0008031020-2021-00007
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number657334S
Device Catalogue Number657334S
Device LOT NumberY57954
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/30/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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