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Catalog Number UNK_KIE
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 11/01/2012
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device disposition is unknown.
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(4). The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of femoral fractures with the t2 nailing systems¿ which was published in november 2018 and is associated with the t2 femoral nailing system (t2 femur a/r). Within that publication, post-operative complications/ adverse events were reported, which occurred between november 2012 to september 2017. 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 55 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses severe pain persistent 3 months after surgery (device-related). 1 out of 2 cases. The report states, "subject 5-8 was a (b)(6) year old caucasian female, who fell from standing, injuring her right (closed isolated) femur. A t2 femur nail was placed in the retrograde, static compression mode, with 1 proximal locking a/p screw and 3 distal locking m/l screws. History significant for previous tobacco use, diabetes, osteoporosis, chronic right knee pain, right hip and back pain without history of trauma, degenerative joint disease, meniscal tear, and vitamin d deficiency; distal femur stress fracture prior to the day of admission found on an mri of the knee. Subject was discharged on pod#4, partial weightbearing. At the 3 month post-op follow-up visit, subject c/o pain and discomfort of the knee, medially. Fracture is healed. Subject was instructed to follow-up in 3 months or sooner if pain worsens. Surgeon noted distal most screw may be slightly long. Subject never returned for another follow-up. ".
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Type of DeviceIMPLANT
Manufacturer (Section D)
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
MDR Report Key8096089
MDR Text Key128188188
Report Number0009610622-2018-01475
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 literature
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
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 Received11/15/2018
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: 11/21/2018 Patient Sequence Number: 1