MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. Ø4.5X110MM; PLATE, FIXATION, BONE

Catalog Number 340710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Itching Sensation (1943)

Event Date 11/27/2019

Event Type  Injury  

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 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.".

• Brand Name: CORTEX SCREW S.T. Ø4.5X110MM
• Type of Device: PLATE, 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 Key: 9513197
• MDR Text Key: 185263364
• Report Number: 0008031020-2019-02341
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327080896
• UDI-Public: 07613327080896
• Combination Product (y/n): N
• PMA/PMN Number: K050512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 340710
• Device Lot Number: 03365F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other