FDA Adverse Event
Injury
Summary report: N
VITOSS
MDR report key: 17530095
·
Received August 12, 2023
Report
- Report Number
- MW5137015
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- October 15, 2013
- Manufacturer
- ORTHOVITA, INC.
- Product Code
- MQV
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
LT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2008 THE PATIENT SUSTAINED AN UNKNOWN INJURY. ON AN UNKNOWN DATE IN 2009 THE PATIENT HAD L5/S1 ANTERIOR FUSION SURGERY FOR PLACEMENT OF ONE COMPETITOR'S BONE GRAFT, ONE ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPACER, ONE SACRAL PLATE AND FOUR LOCKING SCREWS. THE PATIENT HAS A HISTORY OF BACK PAIN, SEVERE LEG MUSCLE PAIN, ALL OVER MUSCLE PAIN, RANDOM BURNING AND SHOOTING PAIN. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072927 | VITOSS | FILLER, BONE VOID, CALCIUM COMPOUND | MQV | ORTHOVITA, INC. | B810001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |