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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS/HOWMEDICA OSTEONICS CORP SCREW 5X42MM LOCK T2; SCREW, FIXATION, BONE
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STRYKER ORTHOPAEDICS/HOWMEDICA OSTEONICS CORP SCREW 5X42MM LOCK T2; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 2360-5042S
Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Pain (1994)
Event Type  Injury  
Event Description
Event description: on or about (b)(6) 2022 the patient sustained injuries as a result of trip and fall over a security band on the exterior sidewalk premises of the store.On or about (b)(6) 2022 the surgeon performed a right femur distal fracture surgical repair.On or about (b)(6) 2023 the patient underwent second surgery to replace the depuy hardware installed due to infection related to surgery, depuy hardware was defective in design and/or manufacture and past and present pain and suffering he allegedly sustained.This complaint involves unknown number of devices.Reference reports: mw5144705, mw5144706, mw5144707, mw5144708, mw5144709, mw5144710, mw5144711, mw5144712, mw5144713, mw5144714, mw5144715, mw5144716, mw5144717, mw5144718, mw5144719, mw5144720, mw5144721, mw5144722, mw5144723, mw5144724, mw5144725, mw5144726, mw5144727, mw5144729, mw5144730.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
SCREW 5X42MM LOCK T2
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS/HOWMEDICA OSTEONICS CORP
MDR Report Key17572865
MDR Text Key321621361
Report NumberMW5144728
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 08/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number2360-5042S
Device Lot NumberKO20FB3
Patient Sequence Number1
Treatment
29 HOLE RIGHT BROAD PLATE.; CHIPS 30ML 4-10MM CANC.; KT GRAFT 10ML STIMULAN.; KT GRAFT 20ML STIMULAN.; KWIRE TROCAR TIP.; MATRIX 10ML VIVIGEN LRG.; NAIL FEM RETROGRADE.; SCREW 5X42MM LOCK T2.; SCREW 5X50MM LOCK T2.; SCREW 5X80MM.; SCREW 5X85.5MM LOCK T2.; SCREW CORTICAL 3.5X34MM.; SCREW CORTICAL.; SCREW LOCK 3.5X48MM.; SCREW LOCK 4.0X40MM.; SCREW LOCK 4.0X50MM.; SCREW LOCK 4.5X44MM.; SCREW LOCK 4.5X46MM.; SCREW LOCK 4.5X48MM.; SCREW LOCK 4.5X90MM.; SCREW LOCK 4.5X95MM.; SCREW LOCK 5X80.; SCREW LOCK 5X80MM.; SCREW LOCK 5X85MM.; SCREW NLCK 3.5X28MM.
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