FDA.reportPublic FDA data

MAUDE MDR 8705160

MDR report key
8705160
Report number
1526439-2019-51769
Event key
0
Event type
3
Date of event
2019-05-28
Date received
2019-06-17
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
KARA DITTY-BOVARD
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1XPDM THORACIC PEDICLE PRB, CRVPROBEDEPUY SPINE INCHXB279702040279702040NW136373Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-170

Event Narratives#

N

Patient 1

(B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION 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

IT WAS REPORTED THAT ON (B)(6) 2019, DURING A POSTERIOR SPINAL FUSION ON A PATIENT WITH HARD BONE, WHILE CREATING A PATHWAY FOR THE SCREW INTO THE PEDICLE, THE THORACIC PROBE BROKE AT THE DISTAL END TIP. THIS PIECE WAS RETRIEVED AND NOTHING WAS LEFT INSIDE THE PATIENT. ALSO, WHEN DOING FINAL TIGHTENING, THE TORQUE DRIVER SHAFT STRIPPED AT THE DISTAL END TIP. THERE WERE FRAGMENTS GENERATED BUT WAS EASILY REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT SUFFER DUE TO THESE BRAKES. CONCOMITANT DEVICE REPORTED: UNKNOWN POLYAXIAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES.