OtherLOD

SIMPLEX P WITH TOBRAMYCIN

Received May 5, 2005 · Event occurred Dec 3, 2004

Report 604173 · MDR key 604173

Device

Generic name

Bone Cement

Manufacturer

Howmedica International S. De R.l.

Model number

Catalog number

Lot number

MDL010

Product problems

Unknown (for use when the device problem is not known)

Patient

87 YR

Death
Low Oxygen Saturation
Blood pressure, low
Intubation
Treatment with medication(s)
Hospitalization required
Diminished Pulse Pressure

Narrative

Description of Event or Problem

PT UNDERWENT KYPHOPLASTY, 3 LEVELS WITH THE INJECTION OF BONE CEMENT. SHORTLY AFTER THE PROCEDURE ENDED AT 922, THEIR O2 SATS DROPPED FROM 98 TO 88, BP FROM 102/56 TO 102/40, PULSE DECREASED TO 40. PT WAS INTUBATED AFTER A POOR RESPONSE TO MEDICATIONS AND TRANSFERRED TO ICU. THE PT EXPIRED A1030.