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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE? MTP, RIGHT ANCHORAGE PLATE, FIXATION, BONE

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STRYKER GMBH CROSS PLATE? MTP, RIGHT ANCHORAGE PLATE, FIXATION, BONE Back to Search Results
Model Number PLP14342
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Plate failed to accept locking screws. Prolonged the case by 5 minutes to switch to different plate.
 
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Brand NameCROSS PLATE? MTP, RIGHT ANCHORAGE
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9748401
MDR Text Key193408586
Report Number0008031020-2020-00515
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083447
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 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPLP14342
Device Catalogue NumberPLP14342
Device Lot NumberD25248
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/27/2019
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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