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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965035S
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 10/19/2016
Event Type  Injury  
Manufacturer Narrative
Device remains implanted and therefore will not be returned at this time. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
The customer reported to the rep that upon follow up x-ray during fracture clinic the consultant has noticed that screws backed-out of the nail causing the fixation to fail. Date of surgery: (b)(6) 2016. Date that this was noticed: fracture clinic (b)(6) 2016. No adverse events during initial surgery. (b)(6). She has not fallen or used the arm other than with pendula exercises for 2-3 weeks. Three 5mm locking screws backed out. The patient is considering revision to reverse shoulder replacement. If left alone i think her function will be very poor".
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key6114752
MDR Text Key60417543
Report Number0009610622-2016-00511
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18965035S
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 Received10/24/2016
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: 11/18/2016 Patient Sequence Number: 1
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