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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI 3.5MM / L36MM PLATE, FIXATION, BONE

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STRYKER GMBH CORTEX SCREW AXSOS 3 TI 3.5MM / L36MM PLATE, FIXATION, BONE Back to Search Results
Model Number 661436
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
As reported: "dr. Used the ankle fusion plate to fuse the tibiotalar joint. We put in 7 screws (4. 0 locking qty 4, 3. 5 cortex screws qty 2, 6. 5 cannulated screw qty 1) into the plate. The patient came back to clinic today 1/28 in some pain and dr. Took and x-ray and we discovered 3 screws have broken and the plate is sitting of the bone. " additional information: screws broke sometime between 12/17-1/28. The patient came in on 1/28 with pain and swelling of her ankle. We determine through x-ray that the screws failed. Before she was weight bearing as tolerated and now she is in a cam boot. No further action has been planned at the moment. Her activity level is low and she is diabetic. She has had previous surgeries on same foot 6 years ago. Orif or righty tri mal and syndesmotic screws and then hardware removal. Her diabetes is poorly controlled a1c is high.
 
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Brand NameCORTEX SCREW AXSOS 3 TI 3.5MM / L36MM
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 Key11376331
MDR Text Key233557692
Report Number0008031020-2021-00066
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number661436
Device Catalogue Number661436
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
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 Treatment Data
Date Received: 02/24/2021 Patient Sequence Number: 1
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