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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 Ø5X80 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X80 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965080S
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
The surgeon reported that the patient had undergone a t2 recon nail procedure on (b)(6) 2017 and after the procedure it was noticed that the t2 5mm locking screw had backed out.
 
Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure. Therefore, this complaint is closed without further investigation. If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
The surgeon reported that the patient had undergone a t2 recon nail procedure on (b)(6) 2017 and after the procedure it was noticed that the t2 5mm locking screw had backed out.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X80 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key7773464
MDR Text Key116782458
Report Number0009610622-2018-00683
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number18965080S
Device Lot NumberK0E8F46
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/10/2018 Patient Sequence Number: 1
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