FDA Adverse Event
Malfunction
Summary report: N
ARRAY TITANIUM IMPLANTS
MDR report key: 1420749
·
Received April 17, 2009
Report
- Report Number
- 2242816-2009-00021
- Event Type
- Malfunction
- Date Received
- April 17, 2009
- Date of Event
- February 17, 2009
- Report Date
- March 24, 2009
- Manufacturer
- BIOMET
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG # 94410. ADDITIONAL PARTS INVOLVED: CATALOG # 94645, COMMON DEVICE NAME: MNI. CATALOG# 94640, COMMON DEVICE NAME: MNI.
Description of Event or Problem · 1
SURGEON WAS UNABLE TO SECURE ROD WITH THE SET SCREWS. AFTER UNSUCCESSFULLY ATTEMPTING TO LOCK THE SYSTEM IN PLACE, SURGEON DECIDED TO REMOVE THE ROD AND USE A DIFFERENT BIOMET SPINE SYSTEM. PT LEFT UNDER GENERAL ANESTHESIA FOR APPROXIMATELY 1.5 HOURS WHILE THE REPLACEMENT SYSTEM WAS RETRIEVED AND AVAILABLE FOR USE. PT OUTCOME: PT SUBSEQUENTLY ARRESTED AND WAS TRANSPORTED FOR EMERGENCY TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARRAY TITANIUM IMPLANTS | MNI, HSB | MNI | BIOMET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |