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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLATE, STRAIGHT, 24 HOLE, MIDFACE; IMPLANT
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STRYKER LEIBINGER FREIBURG PLATE, STRAIGHT, 24 HOLE, MIDFACE; IMPLANT Back to Search Results
Model Number 55-06724
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)
Event Date 06/30/2020
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device not available for return.
 
Event Description
It was reported by the company representative that the patient experienced non-union/infection of the bone where the plate was implanted.A revision surgery was completed to remove the plate.
 
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Brand Name
PLATE, STRAIGHT, 24 HOLE, MIDFACE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE  D-79111
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE   D-79111
Manufacturer Contact
rylee koole
boetzingerstr. 41
freiburg D-791-11
DE   D-79111
76145120
MDR Report Key10267639
MDR Text Key198686795
Report Number0008010177-2020-00036
Device Sequence Number1
Product Code JEY
UDI-Device Identifier04546540365958
UDI-Public04546540365958
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
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number55-06724
Device Catalogue Number55-06724
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/30/2020
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
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