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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.5MM / L14MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.5MM / L14MM PLATE, FIXATION, BONE Back to Search Results
Model Number PLSL3514
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 NameLOCKING SCREW ANCHORAGE Ø3.5MM / L14MM
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 Key9748425
MDR Text Key193409151
Report Number0008031020-2020-00519
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 04/29/2020
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 NumberPLSL3514
Device Catalogue NumberPLSL3514
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
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

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