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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN PROXIMAL LOCKING SCREW IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN PROXIMAL LOCKING SCREW IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Pain (1994)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a pmcf from (b)(6), usa. The title of this report is ¿a retrospective data collection of the treatment of long bone fractures with the t2 knee arthrodesis nailing system (t2 kan)¿ which is associated with the stryker ¿t2 knee arthrodesis nailing¿ system. Within that publication, post-operative complications/ adverse events were reported, which occurred from january 2012 to january 2019. It was not possible to ascertain specific device/patient details from the report, 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 2 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses neuropathy caused persistent pain. The report states: ¿unfortunately, he did have persistent pain in the left lower extremity related to his neuropathy. His last follow up in the office was on (b)(6) 2016. Of note, his weight increased to a bmi of 60 at that time. ¿.
 
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Brand NameUNKNOWN PROXIMAL LOCKING SCREW
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9769347
MDR Text Key192723839
Report Number0009610622-2020-00082
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 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
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 Received02/03/2020
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: 02/28/2020 Patient Sequence Number: 1
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