CERVICAL CURETTE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-06 for CERVICAL CURETTE manufactured by Symmetry Surgucal Inc.

Event Text Entries

[148273050] The product code and lot number is unknown as the product code has been rubbed off the instrument, however the customer also reported that the instrument is over 20 years old. The customer will be returning the device and we will be able to determine the cup size and part number. Once we have obtained additional information, a follow-up report will be submitted. (b)(6). (b)(4). The delay in the fda receiving this complaint was due to a change in e-signature certificates.
Patient Sequence No: 1, Text Type: N, H10


[148273051] During a cervical spine surgery, the tip of the curette broke off and fell into the patient. The piece was successfully removed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007208013-2019-00008
MDR Report Key8676188
Date Received2019-06-06
Date of Report2019-03-19
Date of Event2018-12-02
Date Mfgr Received2019-02-27
Date Added to Maude2019-06-06
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 FDA3
Event Location3
Manufacturer ContactBRANDI MEATH
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH TN 37013
Manufacturer CountryUS
Manufacturer Postal37013
Manufacturer G1SYMMETRY SURGICAL INC
Manufacturer Street3034 OWEN DRIVE
Manufacturer CityANTIOCH TN 37013
Manufacturer CountryUS
Manufacturer Postal Code37013
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameCERVICAL CURETTE
Product CodeFZS
Date Received2019-06-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYMMETRY SURGUCAL INC
Manufacturer Address3034 OWEN DRIVE ANTIOCH TN 37013 US 37013


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-06

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