FDA.reportPublic FDA data

MAUDE MDR 9845910

MDR report key
9845910
Report number
3004788213-2020-00036
Event key
0
Event type
3
Date of event
2019-01-22
Date received
2020-03-17
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
MS. FLORENCE MAILY
Address
QUARTIER EUROPE DE L 5, RUE DE BERLIN SAINTE-SAVINE, NA 10300 FR
Phone
333-333-3338
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MOBI-C P&F IMPLANT 17X19 H5SEE H10LDR M?DICALMJONAMB2795L082056Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1701. H; 2. R

Event Narratives#

N

Patient 1

THIS DEVICE IS NOT CLEARED FOR USE WITHIN THE US; HOWEVER IT IS SIMILAR TO A DEVICE THAT IS CLEARED FOR USE WITHIN THE US. COMMON DEVICE NAME: THIS IS SIMILAR TO MOBI-C CERVICAL DISC PROSTHESIS. PMA/510(K) NUMBER: THIS IS SIMILAR TO P110009. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER. HOWEVER, A FULL EVALUATION WAS UNABLE TO BE PERFORMED SINCE THE NECESSARY DECONTAMINATION RECORDS WERE NOT PROVIDED. THE PROVIDED X-RAY SHOWS THE INFERIOR PLATE HAS MIGRATED, AND THE CORE HAS ALSO LIKELY MIGRATED. A VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY OBVIOUS INDICATIONS OF DAMAGE OR MALFUNCTION. THE CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. A REVIEW IF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE'S LABELING PROVIDES INSTRUCTIONS ON PROPER SITE PREPARATION AND DEVICE INSTALLATION.

D

Patient 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C DEVICE AT C5/6 THAT HAD BEEN IMPLANTED FOR ABOUT 2 MONTHS BECAUSE OF DEVICE MIGRATION THAT WAS CAUSING LEFT ARM PAIN AND WEAKNESS. A COMPETITOR'S PRODUCT WAS INSTALLED DURING THE REVISION SURGERY.