FDA Adverse Event
Malfunction
Summary report: N
KYPHX HV-R BONE CEMENT
MDR report key: 1832347
·
Received September 3, 2010
Report
- Report Number
- 2953769-2010-00380
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- May 9, 2007
- Report Date
- May 16, 2007
- Manufacturer
- MEDTRONIC SPINE LLC
- Product Code
- NDN
- PMA / PMN Number
- K041584
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - DEVICE NOT RETURNED, FOLLOWED UP WITH COMPANY REP.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A KYPHOPLASTY PROCEDURE AT LEVEL L4. REPORTEDLY, THE PT WAS ALLERGIC TO BARIUM SO GADOLINIUM WAS UTILIZED AS A CONTRAST AGENT. IT WAS ALSO NOTED THAT AN ANTIBIOTIC, "ANGENOMYCEIN" WAS ADDED TO THE CEMENT DUE TO THE PT ALLERGIC TO SULFA. NO ADVERSE EVENT TO PT OUTCOME WAS REPORTED. NO ADDITIONAL INFO WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX HV-R BONE CEMENT | HIGH VISCOSITY, RADIOPAQUE BONE CEMENT | NDN | MEDTRONIC SPINE LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |