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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX BONE SCREW IMPLANT

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STRYKER GMBH UNKNOWN VARIAX BONE SCREW IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Material Fragmentation (1261)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "variax dr removal surgery. There was something like wire wrapped around the bone screw. ".
 
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Brand NameUNKNOWN VARIAX BONE SCREW
Type of DeviceIMPLANT
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10423188
MDR Text Key204706658
Report Number0008031020-2020-02181
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
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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