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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
Catalog Number PLP14342
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The pharmacist from the hospital reported the following event: "plate for arthrodesis mtp right foot 'asked the' (b)(6) 2016, found broken in the foot of the patient. Consequences of the incident: changing the plate (1 plate, 2 screws 18 and 2 screws 16). ".
 
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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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8171046
MDR Text Key130555753
Report Number0008031020-2018-01071
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
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPLP14342
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 Received11/21/2018
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: 12/17/2018 Patient Sequence Number: 1
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