SMALL CURRETTE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-10 for SMALL CURRETTE manufactured by Life Instrument.

Event Text Entries

[3369432] On (b)(6) 2012, this pt with spinal stenosis with neurogenic claudication l4-5 and compression fracture l4-5 had a laminectomy of l3, posterolateral instrumented spinal fusion l3 to l5, open biopsy of left l4 pedicle, use of calcium phosphate osteoconductive material, use of morsellized allograft bone and a partial l5 laminectomy was also performed. While his fracture was benign in appearance, it was deemed appropriate to perform a biopsy of the vertebral body as well as the left l4 pedicle to ensure that there was no pathologic nature of this fracture. This was done by decorticating the confluence of the transverse process lateral joint surface and pars interarticularis on the left hand side. The pedicle was then breached using a blunt pedicle finder. A small curette was then used to gently remove cancellous bone from the vertebral body as well as the pedicle. While this was being done, the tip of a small angled curet broke off. Attempts were made to remove this. This was not possible. C-arm magnification confirmed appropriate location of this tip in the vertebral body. It was felt that removing this would cause undue harm to both the bony structures and possible neural elements. Given that the instrument was clean and imbedded in the vertebral body, it was also felt that no undue risk would be posed by leaving this piece of hardware in its place.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5028586
MDR Report Key2916397
Date Received2013-01-10
Date of Report2012-12-31
Date of Event2012-10-17
Date Added to Maude2013-01-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSMALL CURRETTE
Generic NameSMALL CURRETTE
Product CodeFZS
Date Received2013-01-10
Returned To Mfg2012-10-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerLIFE INSTRUMENT
Manufacturer Address91 FRENCH AVE BRAINTREE MA 02184 US 02184


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-01-10

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