FDA Adverse Event
Other
Summary report: N
PIEZON MASTER SURGERY TIP
MDR report key: 1565512
·
Received December 2, 2009
Report
- Report Number
- 8030987-2009-00002
- Event Type
- Other
- Date Received
- December 2, 2009
- Date of Event
- October 28, 2009
- Report Date
- December 1, 2009
- Manufacturer
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- Product Code
- DZI
- PMA / PMN Number
- K072146
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS.
Description of Event or Problem · 1
DURING A SINUS LIFT OPERATION IN A DOCTOR'S PRACTICE, THE SL2 (DIAMOND-COATED) INSTRUMENT BROKE IN THE PT'S SINUS DURING THE OPERATION INVOLVING THE OPENING OF A WINDOW. THE SL2 TIP WAS USED IN THE END STAGE FOR THE FINAL OPENING AND ROUNDING OF THE WINDOW. THE DOCTOR DID NOT USE THE TIP FOR THE COMPLETE WINDOW BUT ONLY AT THE END OF THE OPENING. AFTER THE OPERATION WAS BROKEN OFF, THE PT WAS IMMEDIATELY TREATED IN THE HOSPITAL. THE TOTAL PROCEDURE TOOK 2-3 HOURS AT THE DENTAL PRACTICE AND 1-2 HOURS AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIEZON MASTER SURGERY TIP | ULTRASONIC DENTAL SURGICAL SYSTEM TIP | DZI | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | DS-102 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |