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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 14 HOLE / L310MM; PLATE, FIXATION, BONE
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STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627644
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Patient kept the plate.
 
Event or Problem Description
As reported: "came in to cover case for long gamma nail, was told patient had a distal lateral femur plate that broke.Patient also had short gamma nail in.Explanted femur plate and short gamma nail.Put in long gamma nail.When trying to obtain information i was told family had taken the femur plate.".
 
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Brand Name
DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8182723
Report Number0008031020-2018-01076
Device Sequence Number19253514
Product Code HRS
UDI-Device Identifier07613252579687
UDI-Public07613252579687
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K181091
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/19/2018
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? Yes
Operator of Device Lay User/Patient
Device Catalogue Number627644
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2018
Initial Report FDA Received Date12/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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