FDA Adverse Event Injury Summary report: N

MOBI-C CERVICAL DISC PROSTHESIS

MDR report key: 3913777 · Received June 10, 2014

Report

Report Number
3004788213-2014-00010
Event Type
Injury
Date Received
June 10, 2014
Manufacturer
LDR MEDICAL
Product Code
MJO
PMA / PMN Number
P110009
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF THE XRAYS INDICATE SUPERIOR PLATE MIGRATED ANTERIOR ON BOTH DEVICES, LIKELY DUE TO REDUCED ANTERIOR ENDPLATE STRUCTURE. DEVICES WERE RETAINED FOR BIOLOGIC EVAL, RESULTS PENDING.

Description of Event or Problem · 1

REF IMP# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
337433 MOBI-C CERVICAL DISC PROSTHESIS MOBI-C CERVICAL DISC MJO LDR MEDICAL MB3355 5220084

Patients

Seq Age Sex Outcome Treatment
1