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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM PLATE, FIXATION, BONE

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STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM PLATE, FIXATION, BONE Back to Search Results
Model Number 627638
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Limb Fracture (4518); Unequal Limb Length (4534)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

 
Event Description

The customer reported that: "mrs p-mh received an axsos plate ref 627638 lot d19852 on (b)(6) 2020 following a supra-condylar femur fracture dt. On (b)(6) 2021, while climbing a staircase, the patient fell and felt a crack. The ct scan of (b)(6) showed a fracture of the femoral plate and a 2 cm shortening of the femur with an engaged fracture. The patient was operated on again on (b)(6): removal of the plate and a new osteosynthesis by plate and graft decortication. ".

 
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Brand NameDISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12385645
MDR Text Key268727522
Report Number0008031020-2021-00387
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK200398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number627638
Device Catalogue Number627638
Device LOT NumberD19852
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated By Manufacturer? No
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: 08/30/2021 Patient Sequence Number: 1
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