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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PEGA MEDICAL INC. FASSIER-DUVAL TELESCOPIC IM SYSTEM; MALE DRIVER 3.2MM
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PEGA MEDICAL INC. FASSIER-DUVAL TELESCOPIC IM SYSTEM; MALE DRIVER 3.2MM Back to Search Results
Catalog Number MDR132-L
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/14/2020
Event Type  Injury  
Event Description
The male driver broke in the patient's canal.They were able to remove the main broken parts thru the osteotomy.However, small fragments of the instrument remained in the canal.
 
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Brand Name
FASSIER-DUVAL TELESCOPIC IM SYSTEM
Type of Device
MALE DRIVER 3.2MM
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 H7W 5 J8
CA   H7W 5J8
Manufacturer Contact
enrique garcia
1111 autoroute chomedey
laval, quebec H7W5J-8
CA   H7W5J8
MDR Report Key10040546
MDR Text Key191197441
Report Number3000327445-2020-00003
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMDR132-L
Device Lot Number100702-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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