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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GAMMA 3 LAG SCREW; IMPLANT
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STRYKER TRAUMA KIEL GAMMA 3 LAG SCREW; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Migration (4003)
Patient Problem Injury (2348)
Event Date 08/02/2012
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
During a journal article review, it was discovered that there was a case of complication (pfna 1 case), which was cut-out of the femoral head.Cut-out of the femoral head occurred in the case of surgery using proximal femoral nail anti-rotation for intertrochanteric fracture.The position of the femoral head of the lag screw was good.However, postoperative 6 months radiograph shows cutting out of the pfna blade.Revision surgery was done with cemented bipolar hemiarthroplasty.
 
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Brand Name
GAMMA 3 LAG SCREW
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE   D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10347649
MDR Text Key202881714
Report Number0009610622-2020-00414
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/03/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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