FDA.reportPublic FDA data

MAUDE MDR 6792695

MDR report key
6792695
Report number
1526439-2017-10659
Event key
0
Event type
3
Date of event
2017-07-20
Date received
2017-08-14
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
JASON BUSCH
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
1HALO VESTORTHOSIS, CERVICADEPUY-SYNTHES SPINEIQKAF101W062295Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-140

Event Narratives#

N

Patient 1

UNKNOWN GTIN, INCOMPLETE LOT # PROVIDED, UDI IS UNAVAILABLE. A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

ON (B)(6) 2017, THE SURGERY WAS PERFORMED USING THE BREMER HALO VEST SYSTEM. DURING THE SURGERY, THE BACKWARD BELT OF BREMER AIR-FLO VEST SHORT (PART#:AF101W, LOT#: 06229) GOT BROKEN. THE SURGEON HEARD THE BROKEN PART SNAP WHEN HE WAS TIGHTENING THE SCREW, AND THEN THE HANDLE WAS SEPARATED FROM THE SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

N

Patient 1

VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE SCREW ON THE BACK OF THE VEST WAS BROKEN. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE SCREW BREAKING CANNOT BE DETERMINED FROM THE SAMPLES AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE AN UNEXPECTEDLY HIGH AMOUNT OF TORQUE BEING PLACED ON THE SCREW, RESULTING IN THE BOND BETWEEN THE SCREW CAP AND SCREW SHANK FAILING. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.