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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH RECTANGULAR PLATE, SIZE 1 PLATE, FIXATION, BONE

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STRYKER GMBH RECTANGULAR PLATE, SIZE 1 PLATE, FIXATION, BONE Back to Search Results
Catalog Number 40-15031
Device Problem Biocompatibility (2886)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 01/12/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
 
Event Description
It has been reported by the customer that there is a patient with allergic problems that has implanted a variax plate and screw. The allergic problem has been detected some time after the surgery.
 
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Brand NameRECTANGULAR PLATE, SIZE 1
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7245364
MDR Text Key99152596
Report Number0008031020-2018-00086
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K063875
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number40-15031
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
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

Patient Treatment Data
Date Received: 02/06/2018 Patient Sequence Number: 1
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