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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/01/2011
Event Type  Death  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided. If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.
 
Event Description
The manufacturer became aware of a study from st. Cloud orthopedics, mn, united states. The title of this report is ¿enhanced cephalomedullary nail lag screw placement and intraoperative tip-apex distance measurement with a novel computer assisted surgery system¿ and is associated with the stryker adapt & gamma nailing system which was published on october 2016. Within that publication, post-operative complications/ adverse events were reported occurred from 1-september- 2011 to 2-april-2014. It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 18 complaints were initiated retrospectively for different adverse events mentioned in the study. This product inquiry addresses patient death. 2 out of 14 cases. The cause and the date of the death is unknown and will not be disclosed.
 
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Brand NameUNKNOWN GAMMA3 NAIL
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 Key8843470
MDR Text Key152744796
Report Number0009610622-2019-00593
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received07/11/2019
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: 07/30/2019 Patient Sequence Number: 1
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