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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report. Device disposition is unknown.
 
Event Description
It was reported that a gamma nail broke at the lag screw hole 4 months post-op. Revision surgery was scheduled for (b)(6) 2021. More information about the revision has not been provided.
 
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Brand NameUNKNOWN GAMMA NAIL
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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12509610
MDR Text Key272575617
Report Number0009610622-2021-00700
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
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: 09/21/2021 Patient Sequence Number: 1
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