FDA Adverse Event
Malfunction
Summary report: N
MACROPORE FRP SCREW, 1.8 X 4 MM, 4-PACK
MDR report key: 1480255
·
Received July 16, 2009
Report
- Report Number
- 2021898-2009-00141
- Event Type
- Malfunction
- Date Received
- July 16, 2009
- Date of Event
- June 17, 2009
- Report Date
- June 18, 2009
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JEY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. ADD'L LOT NUMBER: C40823.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SOME OF THE MACROPORE SCREWS DID NOT SEEM AS DURABLE AND THAT THE SCREWS HEAD WERE BREAKING DURING THE TIGHTENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MACROPORE FRP SCREW, 1.8 X 4 MM, 4-PACK | JEY | MEDTRONIC NEUROSURGERY | NA | C37946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |