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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 LOCKING SCREW IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN T2 LOCKING SCREW IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Device Slipped (1584)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Event Date 03/19/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Implant disposition is unknown.
 
Event Description
It was reported that four-and-a-half years ago, tka with scorpio nrg ps and osteotomy with t2 femoral nail for oa with varus deformation were performed. A 3 months after the surgery, the varus deformation progressed and the most distal locking screw of t2 nail has come loose. The patient felt pain, so extraction of the screw was performed. Further 16 months after, patella fracture was occurred because the patient fall. Now, the patient feels no pain and walk by oneself, but the varus deformation of the femoral is remained. This case was presented at great expectations 2016 stryker (b)(4) hip & knee symposium on 3/19/2016.
 
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Brand NameUNKNOWN T2 LOCKING SCREW
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5592153
MDR Text Key43158320
Report Number0009610622-2016-00214
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received03/23/2016
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: 04/20/2016 Patient Sequence Number: 1
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