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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 SHORT NAIL 11X180 IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 SHORT NAIL 11X180 IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Collapse (1099)
Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Hospital retained.
 
Event Description
It was reported that the patient's right femur was revised due to collapse of the patient's femoral neck (non-union). Surgeon reported the devices were not responsible for the failure, but due to several patient factors (poor protoplasm, smoking, and other factors). The gamma3 short nail, lag screw, and locking screw were revised to a hip replacement with restoration modular devices. Rep confirmed that no further information is available.
 
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Brand NameUNKNOWN GAMMA3 SHORT NAIL 11X180
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9307312
MDR Text Key170520355
Report Number0009610622-2019-00917
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
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 Received10/16/2019
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: 11/11/2019 Patient Sequence Number: 1
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