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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VET LC-DCP 3.5 6HO L80 SST PLATE,FIXATION,BONE

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SYNTHES GMBH VET LC-DCP 3.5 6HO L80 SST PLATE,FIXATION,BONE Back to Search Results
Catalog Number VP3041.06
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2015, the veterinary patient underwent surgery with the lc-dcp plate in question treating spiral tibial fracture. Approximately six (6) years post-operation, the physicians report lameness of the leg, osteolysis of the proximal tibia near the plate, and development of osteosarcoma at the level of the plate in the proximal left tibia. There is no further information available. This report is for one (1) vet lc-dcp 3. 5 6ho l80 sst. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device is a veterinary product. No patient information will be reported. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameVET LC-DCP 3.5 6HO L80 SST
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13001917
MDR Text Key282212343
Report Number8030965-2021-10191
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVP3041.06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

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