FDA.reportPublic FDA data

MAUDE MDR 9638552

MDR report key
9638552
Report number
3007494564-2020-00002
Event key
0
Event type
3
Date of event
2020-01-07
Date received
2020-01-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JASON SMITH
Address
900 AIRPORT RD, SUITE 3B WEST CHESTER PA 19380 US
Phone
484-484-4848
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PRODISC L POLYETHYLENE INLAY W/TANTALUM MARKER LARGE 10MMPROSTHESIS, INTERVERTEBRAL DISCCENTINEL SPINE, LLC.MJOPDL-L-PT10SH436470N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2801. R

Event Narratives#

N

Patient 1

INFORMATION PROVIDED BY THE REPORTER INDICATES THE PRODISC L INFERIOR ENDPLATE MIGRATED ANTERIORLY. IMAGES OF THE PATIENT INDICATED THE PATIENT SUFFERED A PEDICLE FRACTURE WHEN THEY FELT THE DESCRIBED "POP" SENSATION. THE SURGEON INDICATED THEY DID HAVE ANY INFORMATION INDICATING HOW THE FRACTURE OR MIGRATION OCCURRED. IT IS NOT KNOWN IF THE MIGRATION MAY HAVE CAUSED OR CONTRIBUTED TO THE PEDICLE FRACTURE. IT IS NOT KNOWN IF THE FRACTURE MAY HAVE CAUSED OR CONTRIBUTED TO THE DEVICE MIGRATION. REVIEW OF DEVICE HISTORY RECORDS DID NOT INDICATE ANY ISSUES IN MANUFACTURING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE RISKS ASSOCIATED WITH THE REPORTED EVENT ARE IDENTIFIED WITHIN THE RISK ASSESSMENT FOR THIS DEVICE. THERE HAS BEEN NO INDICATION IN A TREND OF COMPLAINTS TO SUGGEST CORRECTIVE ACTION IS NECESSARY. THE DEVICE WAS SUCCESSFULLY RETRIEVED, AND AS OF THIS REPORT IS UNDER EVALUATION BY A THIRD PARTY TESTING LABORATORY.

D

Patient 1

PATIENT UNDERWENT REVISION SURGERY TO REMOVE A PRODISC L CONSTRUCT FROM THE L5-S1 DISC SPACE. THE PATIENT EXPERIENCED A "POP" SENSATION DUE TO UNKNOWN CIRCUMSTANCES POST OPERATIVELY. THE PATIENT WAS EXPERIENCING PAIN WHEN LYING DOWN. THE SURGEON DISCOVERED VIA X-RAY THAT THE PATIENT SUFFERED A PEDICLE FRACTURE, AND THE PRODISC L INFERIOR ENDPLATE HAD MIGRATED ANTERIORLY. THE SURGEON DETERMINED MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE PRODISC L CONSTRUCT AND REPLACE IT WITH AN ALIF USING MIDLINE II-TI CAGE AND MIDLINE ABO SCREWS.