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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 Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Date 03/12/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
 
Event Description
After placing a gamma nail, the patient has a dermatologic reaction. Dermatologist therefore asks the composition of the gamma nail.
 
Manufacturer Narrative
The reported event that unknown gamma nail was alleged of k-110 [adverse impact on patient / patient related / iatrogenic issue] could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. Allergic reaction is known from a similar case regarding a trochanteric nail kit, ti gamma3 which was forwarded to a hcp for a surgical statement which states as following: ¿from a clinical point of view the gamma titanium nail is one of the most implanted intramedullary nails for the treatment of trochanteric and proximal femoral fractures with best state of the art clinical results. Compared to the orthinox® gamma nails the titanium nails feature approx. 30 % lesser strength but a better biocompatibility especially with a reduced risk of metal allergy and a lower risk of infection due to its excellent coating features (type ii anodisation). ¿ general information from ¿gamma3 system risk management file / rmf id a0001235_rev. 6¿: ¿under normal circumstances wear parts or metallic debris may remain in the body without any notable harm (s1). Only in very rare cases (e. G. In the case of a (assumed) allergic reaction) a removal of the particles would be required (s3). ¿ ifu l22000007 refers under chapter ¿contraindications¿: material sensitivity, documented or suspected. Other medical or surgical conditions which would preclude the potential benefit of surgery. ¿ ¿adverse effects¿: ¿in many instances, adverse results may be clinically related rather than device related. The following are the most frequent adverse effects involving the use of internal fracture fixation devices: material sensitivity reactions in patients following surgical implantation have rarely been reported, however their significance awaits further clinical evaluation. Although details of the current reported device and planned revision, kind of medication were requested repeatedly but not provided and thus, an individual medical statement was impossible in this case. The file will be closed formally. In case the item and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause. Device remains implanted.
 
Event Description
After placing a gamma nail, the patient has a dermatologic reaction. Dermatologist therefore askes the composition of the gamma nail.
 
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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
MDR Report Key7339067
MDR Text Key102437799
Report Number0009610622-2018-00074
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/14/2018 Patient Sequence Number: 1
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