FDA.reportPublic FDA data

MAUDE MDR 7619531

MDR report key
7619531
Report number
8010386-2018-00005
Event key
0
Event type
3
Date of event
2018-04-01
Date received
2018-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. MARKUS PAULI
Address
UHLANDSTRASSE 17 RIETHEIM-WEILHEIM, 78604 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEGMANUAL RONGEURS.U.A. MARTIN GMBH &CO.KGHAENL3785-164 / 0110814XMEA 03Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-200

Event Narratives#

N

Patient 1

THE DEVICE WAS MANUFACTURED IN 1998 AND THE PHOTOGRAPHS PROVIDED BY THE DISTRIBUTOR SHOW SIGNS OF CONSIDERABLE WEAR. THE MANUFACTURER IS AWAITING RETURN OF THE DEVICE TO PERFORM A COMPLETE EVALUATION.

D

Patient 1

MEDWATCH REPORT STATES: #1 KERRISON INSTRUMENT USED DURING POSTERIOR CERVICAL INSTRUMENTATION. TIP OF KERRISON NOTED TO HAVE BROKEN OFF DURING PROCEDURE. RADIOGRAPHIC CONFIRMATION OBTAINED THAT TIP OF INSTRUMENT WAS NOT RETAINED IN PATIENT. SUCTION FILTER WAS RADIOGRAPHED AND TIP FOUND TO BE SEATED IN FILTER OF THE SUCTION MACHINE. CPD (CENTRAL PROCESSING DEPARTMENT) MANAGER NOTIFIED. BROKEN INSTRUMENT ISOLATED W/ SUCTION FILTER AND GIVEN TO CENTRAL PROCESSING DEPARTMENT WHO DISMANTLED SUCTION FILTER AND SIFTED PIECE OUT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: DECOMPRESSION AND FUSION POSTERIOR CERVICAL SPINE ONE LEVER- C2-C7 FUSION POSTERIOR CERVICAL SPINE THREE OR MORE LEVELS- LAMINECTOMY CERVICAL SPINE WITH DECOMPRESSION AND INSTRUMENTATION TWO LEVELS PATIENT WAS NOT HARMED IN THIS INCIDENT. ON 11MAY2018 ADDITIONAL INFORMATION: 1. IS IT NORMAL PROCEDURE TO TAKE AN X-RAY OF THE PATIENT OR WAS THIS ONLY DONE TO VERIFY THE LOCATION OF THE BROKEN TIP OF THE INSTRUMENT? IT IS STANDARD PROCEDURE TO HAVE C-ARM (X-RAY) IN THE ROOM DURING THIS PROCEDURE. X-RAY IS USED TO CONFIRM PLACEMENT OF INSTRUMENTATION DURING AND IMMEDIATELY PRIOR TO PATIENT LEAVING THE OPERATING ROOM (OR).