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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA 3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA 3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device disposition unknown.
 
Event Description
The manufacturer became aware of a literature published by the department of orthopaedic surgery, liv hospital, (b)(4). The title of this report is ¿reverse oblique and transverse intertrochanteric femoral fractures treated with the long cephalomedullary nail ¿, published on march 26, 2015, which is associated with the stryker ¿gamma 3 nailing¿ system. The article can be found at https://doi. Org/10. 1097/bot. 0000000000000340. This report includes analysis of the clinical data that was collected on 149 patients, the cases in this study range from january 2000 and march 2013. During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available. It was reported that 1 patient experienced peri-implant fractures (pif) requiring revision.
 
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Brand NameUNKNOWN LONG GAMMA 3 NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14060236
MDR Text Key293616448
Report Number0009610622-2022-00128
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Literature
Reporter Occupation
Type of Report Initial
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
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
Date Manufacturer Received03/15/2022
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: 04/08/2022 Patient Sequence Number: 1
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