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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - RIGHT PLATE, FIXATION, BONE

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STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - RIGHT PLATE, FIXATION, BONE Back to Search Results
Catalog Number PLP11342
Device Problems Fitting Problem (2183); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The following event was reported by clinic: despite the use of the barrel on the plate anchorage mtp right (ref plp11342), the screw diameter 3 locking does not fit correctly in the hole. Threading problem was observed and 1 wire came out of the screw. The screw protrudes from the plate and a metal wire comes out of the screw. The screw was removed and another screw reinserted.
 
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Brand NamePLATE ANCHORAGE MTP / VERSION V2 - RIGHT
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 Key8356235
MDR Text Key137429455
Report Number0008031020-2019-00070
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K083447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPLP11342
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/20/2019 Patient Sequence Number: 1
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