D
Patient 1
A PROGENY SALES REPRESENTATIVE REPORTED THAT THE MECHANICAL STRUCTURE OF A PREVA INTRAORAL UNIT, (B) (4), SEPARATED FROM ITS WALL MOUNT, AT DR. (B) (6) DENTAL OFFICE. NO INJURY WAS REPORTED.
MAUDE MDR 1545019
- MDR report key
- 1545019
- Report number
- 1423380-2009-00022
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-10-14
- Date received
- 2009-11-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LISA BARTAKOVICS
- Address
- 675 HEATHROW DR LINCOLNSHIRE IL 60069 US
- Phone
- 847-847-8474
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PROGENY PREVA | MIDMARK CORPORATION | MUH | PREVA | P7017-P | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-11-12 | 0 |
Event Narratives#
N
Patient 1
RESULTS: THE ROOT CAUSE OF THIS CASE IS NOT CLEAR. BASED ON THE ANALYSIS FROM PROGENY DESIGN ENGINEERING, THE POSSIBLE ROOT CAUSES ARE: OVERSIZED PILOT HOLE, STRIPPED HOLE, OR NON-STANDARD INSTALLATION (DRYWALL THICKNESS EXCEED 3/8"). CONCLUSION: IMPROPER INSTALLATION - THE ROOT CAUSE OF THIS CASE IS NOT CLEAR. BASED ON THE ANALYSIS FROM PROGENY DESIGN ENGINEERING, THE POSSIBLE ROOT CAUSES ARE: OVERSIZED PILOT HOLE, STRIPPED HOLE, OR NON-STANDARD INSTALLATION (DRYWALL THICKNESS EXCEED 3/8"). THE UL REPORT OF A STANDARD PROGENY SYSTEM MOUNT (2 3/8" X 3" LAG SCREWS ON 2/4 STUD) DEMONSTRATES THAT A CORRECTLY INSTALLED X-RAY UNIT CAN WITHSTAND 6 TIMES THE SYSTEM WEIGHT.