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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D/M 8.0 IN SS BROAD COMP PLATE PLATE, FIXATION, BONE

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STRYKER ORTHOPAEDICS-MAHWAH D/M 8.0 IN SS BROAD COMP PLATE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 3704-3-110
Device Problems Break (1069); Fracture (1260)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Event Date 04/05/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other events for the lot referenced. It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not returned.
 
Event Description
Biomedical engineer from the hospital reported the following event: "moderate slip in the bathroom. Thigh deformity appeared. Impotence and disability. Partial fracture of the plate found on x-ray on (b)(6) 2018. Change of material on (b)(6) 2018. ".
 
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Brand NameD/M 8.0 IN SS BROAD COMP PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7703097
MDR Text Key114454208
Report Number0002249697-2018-02224
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327036633
UDI-Public07613327036633
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K922525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number3704-3-110
Device Lot Number56919401
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 Received08/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2016
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: 07/19/2018 Patient Sequence Number: 1
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