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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLATE, CURVED, 10 HOLE, UPPERFACE; IMPLANT

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STRYKER LEIBINGER FREIBURG PLATE, CURVED, 10 HOLE, UPPERFACE; IMPLANT Back to Search Results
Model Number 55-06250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/20/2023
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
 
Event Description
It was reported that the patient had implants placed a year ago and was experiencing pain.Patient requested for the devices to be removed.Surgeon performed a second surgery to remove the devices and surgeon noted there were no issues with the devices.
 
Event Description
It was reported that the patient had implants placed a year ago and was experiencing pain.Patient requested for the devices to be removed.Surgeon performed a second surgery to remove the devices and surgeon noted there were no issues with the devices.
 
Manufacturer Narrative
Update: h6 corrected data: it has been confirmed by a medical expert that the stryker device did not cause and/or contribute to the event as described; therefore, the mdr record that was filed, is not valid.Please see communication attached in the communication log.H3 other text : not available.
 
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Brand Name
PLATE, CURVED, 10 HOLE, UPPERFACE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM  D-79111
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM   D-79111
Manufacturer Contact
rylee koole
boetzingerstr. 41
freiburg D-791-11
GM   D-79111
7614888208
MDR Report Key16771383
MDR Text Key313602433
Report Number0008010177-2023-00022
Device Sequence Number1
Product Code JEY
UDI-Device Identifier04546540365828
UDI-Public04546540365828
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/29/2023
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
Device Operator Health Professional
Device Model Number55-06250
Device Catalogue Number55-06250
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/20/2023
Initial Date FDA Received04/19/2023
Supplement Dates Manufacturer Received03/20/2023
Supplement Dates FDA Received06/29/2023
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 Number1
Patient Outcome(s) Required Intervention;
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