KYPHX LATITUDE II CURETTE 8.0MM T-TIP A11B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-24 for KYPHX LATITUDE II CURETTE 8.0MM T-TIP A11B manufactured by Medtronic Spine Llc.

Event Text Entries

[15144013] It was reported that a pt underwent a kyphoplasty procedure on (b)(6) 2007 at t7 and l2. During the procedure, an expired curette was used in the pt. There were no pt complications or adverse events reported. No additional info was reported.
Patient Sequence No: 1, Text Type: D, B5


[15454078] Method - device not returned, follow up with company representative. Product was from trunk stock.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2953769-2010-00454
MDR Report Key1846997
Report Source07
Date Received2010-09-24
Date of Report2009-09-11
Date of Event2007-12-14
Date Mfgr Received2009-09-11
Device Manufacturer Date2005-11-01
Date Added to Maude2011-02-02
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 ContactMICHAEL ARMSTRONG, SR. DIR
Manufacturer Street1221 CROSSMAN AVE
Manufacturer CitySUNNYVALE CA 94089
Manufacturer CountryUS
Manufacturer Postal94089
Manufacturer Phone4085486500
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameKYPHX LATITUDE II CURETTE 8.0MM T-TIP
Generic NameCURETTE
Product CodeKAP
Date Received2010-09-24
Model NumberNA
Catalog NumberA11B
Lot NumberJ5111007
ID NumberNA
Device Expiration Date2007-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SPINE LLC
Manufacturer Address1221 CROSSMAN AVE SUNNYVALE CA 94089 US 94089


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-24

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