FDA.reportPublic FDA data

MAUDE MDR 3894524

MDR report key
3894524
Report number
1526439-2014-11630
Event key
0
Event type
3
Date of event
2014-06-02
Date received
2014-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANITA BARNICK
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
508-508-5088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPOTLIGHT 4MM DOWN BITE CURETTECURETTEDEPUY SYNTHES SPINEHTF292903404HG1044283R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-250

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE SPOTLIGHT CURETTE BROKE WHEN BEING USED DURING AN OPEN LAMI/DISCECTOMY PROCEDURE. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THE CASE AND IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EVENT. AS IT IS POSSIBLE THAT THE DISTAL TIP PORTION OF THE CURETTE BROKE DURING USAGE, THIS MEDWATCH REPORT IS BEING FILED TO DOCUMENT THE EVENT.

N

Patient 1

A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

N

Patient 1

THE SPOTLIGHT 4MM DOWN BITING CURETTE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS ON THE PRODUCT FAMILY FOUND NO EMERGING TRENDS. WITHOUT THE RETURN OF THE 4MM DOWN BITING CURETTE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS NECESSARY AT THIS TIME AS WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO SYSTEMIC TREND HAS BEEN OBSERVED. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE SAMPLE OF CONCERN FROM THIS COMPLAINT FILE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.