FDA Adverse Event
Malfunction
Summary report: N
KYPHON HV-R BONE CEMENT
MDR report key: 9584677
·
Received January 14, 2020
Report
- Report Number
- 6000033-2020-00001
- Event Type
- Malfunction
- Date Received
- January 14, 2020
- Date of Event
- December 2, 2019
- Report Date
- January 14, 2020
- Manufacturer
- CARDIAC SURGERY MFG KERKRADE
- Product Code
- NDN
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PMS/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01B, 510K # K041584, UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED VIA OPUS ONE STUDY THAT PATIENT UNDERWENT CEMENTOPLASTY SURGERY DUE TO UNKNOWN REASON. INTRA-OP, CEMENT EXTRAVASATION OCCURRED AT THE INFERIOR DISK SPACE. IT WAS NOT EXTRUDED AND IT WAS NOT CLINICALLY SIGNIFICANT. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52405 | KYPHON HV-R BONE CEMENT | CEMENT, BONE, VERTEBROPLASTY | NDN | CARDIAC SURGERY MFG KERKRADE | NA | 216361200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |