FDA.reportPublic FDA data

MAUDE MDR 4817937

MDR report key
4817937
Report number
2183456-2015-00003
Event key
0
Event type
3
Date of event
2015-03-23
Date received
2015-06-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. KATHLEEN BARLOW
Address
1901 WILLIAM ST. RACINE WI 53404 US
Phone
262-262-2626
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANCHOR BOLT - DOGALI STYLEANCHOR BOLTAD-TECH MEDICAL INSTRUMENT CORP.GCZDGLK1-18X208140545R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-0301. O

Event Narratives#

D

Patient 1

AD-TECH RECEIVED A LETTER AND FOLLOW-UP EMAIL FROM A CUSTOMER STATING THAT ONE (1) ANCHOR BOLT BROKE DURING STEREOTACTIC PLACEMENT OF BILATERAL DEPTH ELECTRODES FOR SEIZURE MONITORING ON A PATIENT, USING THE AD-TECH PLACEMENT WRENCH. A TOTAL OF THIRTEEN (13) ANCHOR BOLTS WERE USED DURING THIS CASE. ON (B)(6) 2015, THE CUSTOMER STATED THAT NO ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED TO ADDRESS THIS ISSUE AT THAT TIME AS THE RETAINED PORTION OF THE BOLT WAS STILL INSIDE THE PATIENT. THERE WAS NO PATIENT HARM. THE CUSTOMER STATED THAT THE BROKEN BOLT WAS HANDED TO RISK MANAGEMENT AND THE RETAINED PORTION WAS STILL INSIDE THE PATIENT. AD-TECH HAS MADE FOUR (4) ADDITIONAL ATTEMPTS TO CONTACT THE CUSTOMER FOR MORE INFORMATION REGARDING THIS CASE, HOWEVER THE CUSTOMER HAS BEEN UNRESPONSIVE.

N

Patient 1

AS STATED, AD-TECH RECEIVED A LETTER FROM CEDAR-SINAI MED CTR REPORTING THIS ANCHOR BOLT ISSUE FOR LOT 208140545. A SECOND FAILURE OF SIMILAR NATURE WAS ALSO MENTIONED IN THIS LETTER FOR AN ANCHOR BOLT FROM LOT 208140543. A SEPARATE MDR WAS FILED FOR THIS ISSUE UNDER 2183456-2015-00002.