FDA Adverse Event
Injury
Summary report: N
KYPHX® HV-R¿ BONE CEMENT
MDR report key: 2981262
·
Received February 27, 2013
Report
- Report Number
- 2953769-2013-00030
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 22, 2013
- Manufacturer
- MDT KYPHON NEUCHATEL MFG
- Product Code
- NDN
- PMA / PMN Number
- K102397
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). LOCATION: HOSPITAL. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, THE CEMENT HARDENED AND THE CEMENT BROKE AND A PIECE WAS LEFT IN THE PEDICLE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83968 | KYPHX® HV-R¿ BONE CEMENT | CEMENT, BONE, VERTEBROPLASTY | NDN | MDT KYPHON NEUCHATEL MFG | 0006442319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |