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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DISTAL POSTERIOR MEDIAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 3 HOLE / L80MM PLATE, FIXATION, BONE

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STRYKER GMBH DISTAL POSTERIOR MEDIAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 3 HOLE / L80MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 629303S
Device Problems Positioning Failure (1158); Device Damaged by Another Device (2915); Positioning Problem (3009)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "during surgery, the locking screw did not lock to the plate. The screw was exchanged to a new one, but the situation was not changed. Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one. The procedure was finished without other problem. " no surgical delay or adverse consequences were reported.
 
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Brand NameDISTAL POSTERIOR MEDIAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 3 HOLE / L80MM
Type of DevicePLATE, FIXATION, BONE
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 Key9099649
MDR Text Key193305781
Report Number0008031020-2019-01295
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K141677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number629303S
Device Lot NumberV18639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2016
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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