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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. Ø4.5X110MM; PLATE, FIXATION, BONE
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STRYKER GMBH CORTEX SCREW S.T. Ø4.5X110MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 340710
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Itching Sensation (1943)
Date of Event 11/27/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
 
Event or Problem Description
The mother of a patient contacted stryker by phone.Her daughter had an allergic reaction (itching) after a surgery with stryker products.An appointment with the dermatologist has already been made.Additionally reported: the itching initially occurred only on the legs, but now on the whole body.".
 
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Brand Name
CORTEX SCREW S.T. Ø4.5X110MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9513186
Report Number0008031020-2019-02340
Device Sequence Number11060197
Product Code HRS
UDI-Device Identifier07613327080896
UDI-Public07613327080896
Combination Product (Y/N)N
PMA/510(K) Number
K050512
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Catalogue Number340710
Device Lot Number03365F
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/27/2019
Initial Report FDA Received Date12/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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