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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 Ø5X42,5 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965042S
Device Problem Break (1069)
Patient Problems Sepsis (2067); Non-union Bone Fracture (2369)
Event Date 01/01/2014
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 manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) university hospital (b)(6). The title of this report is ¿analysis of the t2 recon nail used with the antegrade locking mode¿ which was released in june 2018 and is associated with the t2 recon nailing system. Within that report, postoperative complications/ adverse events were reported, which occurred between january 2014 and november 2017. Based on the available device and patient information and a review of complaint handling database it was revealed that the events have not been reported by the hospital or by the author of the report, therefore 15 complaints were initiated retrospectively for different adverse events mentioned in the journal. This product inquiry addresses septic nonunion discovered from the event of case (b)(4). One out of 1 case. The pmcfr states: ¿in the second case (case (b)(4)) it was a transverse fracture (32-a) in a heavy (b)(6) lady. She is (b)(6). The breakage of all three locking screws was observed. In fact a septic nonunion was observed and a revision surgery was performed 142 days after the initial surgery. All the broken screws were removed (18965050s-k05d869;18965050s-k0af9e2;18965042s-k074ffc), the nail was also removed (18471136s-k0dadeb) the medullary canal was reamed and a t2 a/r nail was then used. Antibiotics were used during 4 months. ¿.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 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 Key7710756
MDR Text Key114768584
Report Number0009610622-2018-00378
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K003018
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18965042S
Device Lot NumberK074FFC
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 Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2016
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: 07/23/2018 Patient Sequence Number: 1
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