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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PEGA MEDICAL INC FASSIER-DUVAL TELESCOPIC IM SYSTEM FD NAIL

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PEGA MEDICAL INC FASSIER-DUVAL TELESCOPIC IM SYSTEM FD NAIL Back to Search Results
Device Problem Fracture (1260)
Patient Problems Congenital Defect/Deformity (1782); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
The device was not evaluated since it was not returned by the customer. Nevertheless, the customer provided x-rays of the failure as well as the following information: "the patient suffered from osteogenesis imperfecta. Initial implantation - (b)(6) 2014 in (b)(6) due broken right femur in (b)(6) 2014. Two fd nails were installed in left femur and tibia and two spokes were also done in right femur and tibia. After rehabilitation the patients was able to walk on a walker at least 60 m and crawl only. Implant removal on the left femur was done on (b)(6) 2018 in (b)(6) clinic (b)(6) because of both legs and nail been broken (one of them an fd nail). Bracing was done on (b)(6) 2018 in (b)(6) clinic (just after several days of the casting). Age - (b)(6) yo now. Time in situ before it broke - 4 years 8 months. " analysis of the provided x-ray show the absence of any plastic deformation of the nail around the breakage indicates that the failure was most likely due to fatigue stresses. There is no apparent bowing of the femur, therefore these stresses were probably due to incomplete healing (non-union) of the bone fracture that generated continuous loading of the implant during a long period of time. Furthermore, it was not possible to review the manufacturing records of the components since implant size and lot# were not available. Nevertheless, considering the time that the implant was implanted in the patient, it does not seem probable that the failure occurred due to a manufacturing problem.
 
Event Description
A fd implant broke in a female patient of (b)(6) yo after 4 year and 8 months of being implanted.
 
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Brand NameFASSIER-DUVAL TELESCOPIC IM SYSTEM
Type of DeviceFD NAIL
Manufacturer (Section D)
PEGA MEDICAL INC
1111 autoroute chomedey
laval, quebec H7W5J 8
CA H7W5J8
Manufacturer (Section G)
PEGA MEDICAL INC
1111 autoroute chomedey
laval, quebec H7W5J 8
CA H7W5J8
Manufacturer Contact
enrique garcia
1111 autoroute chomedey
laval, quebec H7W5J-8
CA   H7W5J8
MDR Report Key8165133
MDR Text Key130362704
Report Number3000327445-2018-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K041393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2018
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: 12/14/2018 Patient Sequence Number: 1
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