FDA Adverse Event
Malfunction
Summary report: N
CRANIOTOME-ATTACHM F/EPD+APD
MDR report key: 3142547
·
Received June 3, 2013
Report
- Report Number
- 8030965-2013-02582
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- March 1, 2013
- Report Date
- May 8, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- DZI
- PMA / PMN Number
- K043310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES: ERL, HBE, HWE. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4)REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2013, THE ELECTRIC PEN DRIVE DEVICE BECAME HEATED AND THE CRANIOTOME ATTACHMENT STOPPED WORKING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245162 | CRANIOTOME-ATTACHM F/EPD+APD | DZI | SYNTHES GMBH | 3570246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |