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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 Ø5X50 MM IMPLANT

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM IMPLANT Back to Search Results
Catalog Number 18965050S
Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device remains implanted.
 
Event Description
The customer reported that 2 x proximal t2 5mm locking screws implanted on (b)(6) 2018 backed out the patient will have the screw re inserted during an upcoming spinal surgery while he¿s asleep.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
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 Key7542284
MDR Text Key109218617
Report Number0009610622-2018-00213
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,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number18965050S
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 Received07/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2018
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: 05/24/2018 Patient Sequence Number: 1
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