CHISEL 10MM PDL322

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-11-06 for CHISEL 10MM PDL322 manufactured by Synthes (usa).

Event Text Entries

[1302241] Surgeon alleges potential chisel involvement related to vertebral body fractures noted post pdl implant. There is no way of knowing which devices were used in which procedures but all 3 were used at the same facility with the same surgeon. This is related to events previously reported to the fda under pdl implant part numbers. This is the first of three reports.
Patient Sequence No: 1, Text Type: D, B5


[8359497] This device is not single use and was used in multiple disc arthroplasty procedures. The surgeon can not determine which chisels were used in which procedures. Device is an instrument and is not implanted. Date of manufacture can not be determined. Investigation could not be completed, no conclusion could be drawn.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1719045-2009-00204
MDR Report Key1525383
Report Source05,07
Date Received2009-11-06
Date of Report2009-10-05
Date Mfgr Received2009-10-05
Date Added to Maude2009-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTRISH MCCARRON
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Manufacturer G1SYNTHES (USA)
Manufacturer Street1101 SYNTHES AVE.
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHISEL 10MM
Generic NameCHISELS
Product CodeEML
Date Received2009-11-06
Model NumberNA
Catalog NumberPDL322
Lot NumberA7OA11
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES (USA)
Manufacturer AddressWEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2009-11-06

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