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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA NAIL, TITAN IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA NAIL, TITAN IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 11/06/2020
Event Type  Injury  
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition is unknown.
 
Event Description
Through a letter from a patient's attorney, we were informed of the following event: on (b)(6) 2020, the patient underwent an open reduction and osteosynthesis using a long gamma nail at the clinic. On (b)(6) 2020, the patient had to be hospitalized again due to pain and was operated on again on (b)(6) 2020, as it turned out that the implant was broken.
 
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Brand NameUNKNOWN LONG GAMMA NAIL, TITAN
Type of DeviceIMPLANT
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12369742
MDR Text Key268207114
Report Number0009610622-2021-00666
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
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: 08/26/2021 Patient Sequence Number: 1
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