FDA Adverse Event
Injury
Summary report: N
INTERGRO
MDR report key: 1352292
·
Received March 26, 2009
Report
- Report Number
- 2242816-2009-00013
- Event Type
- Injury
- Date Received
- March 26, 2009
- Date of Event
- February 20, 2009
- Report Date
- March 3, 2009
- Manufacturer
- EBI, L.P.
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PHYSICIAN REVIEW STATED THAT THIS REPORTED EVENT IS NOT RELATED TO THE PRODUCT. DHR REVIEW INDICATES PRODUCT MET ALL APPLICABLE SPECIFICATIONS.
Description of Event or Problem · 1
THE PATIENT UNDERWENT AN L3-L4 LAMINECTOMY IN 2009. THE PRODUCT WAS IMPLANTED ALONG WITH A MEDTRONIC HARDWARE DEVICE. TWO DAYS LATER, IT WAS REPORTED THE PATIENT HAD AN EPIDURAL HEMATOMA AND A PROCEDURE WAS COMPLETED TO RELIEVE PRESSURE. THERE WAS CERVICAL STENOSIS. THE NEXT DAY, AN EPIDURAL ABCESS WAS CLEANED AT THE ORIGINAL SURGERY SITE. A CULTURE WAS POSITIVE FOR PROPION BACTERIUM ACNES. PATIENT STATUS: PERMANENT DISABILITY (PARALYSIS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERGRO | MQV | EBI, L.P. | 878500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other| R |