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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BONETECH MEDISYS PFNA 212MM 240CM IMPLANT PROXIMAL FEMORAL NAIL ANTIROTATION

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BONETECH MEDISYS PFNA 212MM 240CM IMPLANT PROXIMAL FEMORAL NAIL ANTIROTATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Unspecified Infection (1930); Tissue Damage (2104)
Event Date 06/28/2018
Event Type  Death  
Event Description
On (b)(6) 2018, she had slip in washroom after which xray was done and hip bone fracture was detected. Next day she was admitted and was operated on (b)(6) 2018; compressor which sucks spoiled blood and tissue did not show much. Discharged but later maggots was found on dressing, and blood and urine infection was found hence admitted but every time with infection was going to get cured, came back up with a different bacteria and continued. We had to start dialysis because of that too, again she had been discharged and later on after 20 to 30 days, we came to know that the complete surgery site had been spoiled from within like tissue and muscles, so again admitted her in hosp and later she died with it. More details and files reports can be shared by me on (b)(6).
 
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Brand NamePFNA 212MM 240CM IMPLANT
Type of DevicePROXIMAL FEMORAL NAIL ANTIROTATION
Manufacturer (Section D)
BONETECH MEDISYS
MDR Report Key7876333
MDR Text Key120406602
Report NumberMW5079794
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
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? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/13/2018 Patient Sequence Number: 1
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