FDA Adverse Event
Malfunction
Summary report: N
KYPHON XPEDE BONE CEMENT
MDR report key: 8840269
·
Received July 30, 2019
Report
- Report Number
- 1030489-2019-00839
- Event Type
- Malfunction
- Date Received
- July 30, 2019
- Date of Event
- June 27, 2019
- Report Date
- July 30, 2019
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NDN
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# CX01B; LOT# 0009546988; 510K# K102397; UDI# (B)(4); QTY# 1 PART# UNK; LOT# UNK; QTY: 2 .IT IS UNKNOWN WHICH OF THESE CEMENT HAS EXTRAVASATED. 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 CLINICAL STUDY THAT PATIENT UNDERWENT KYPHOPLASTY SURGERY AT T7. INTRA-OP, 4CC CEMENT EXTRAVASATION OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636841 | KYPHON XPEDE BONE CEMENT | CEMENT, BONE, VERTEBROPLASTY | NDN | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |