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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX PLATE; IMPLANT

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STRYKER GMBH UNKNOWN VARIAX PLATE; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
 
Event Description
Surgeon had trouble locking a locking screw into a variax hand locking plate.
 
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Brand Name
UNKNOWN VARIAX PLATE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8200457
MDR Text Key131709775
Report Number0008031020-2018-01090
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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