FDA Adverse Event
Malfunction
Summary report: N
DAMON COPPER NITI WIRE
MDR report key: 1336378
·
Received March 9, 2009
Report
- Report Number
- 2016150-2009-00016
- Event Type
- Malfunction
- Date Received
- March 9, 2009
- Report Date
- February 10, 2009
- Manufacturer
- ORMCO CORPORATION
- Product Code
- DZC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS INCIDENT. HOWEVER, DUE TO THE PRIOR SUBMISSION OF A REPORTABLE INCIDENT ON THE DAMON COPPER NITI WIRE IN 2008 (MDR #2016150-2008-00001: MALFUNCTION WHICH REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE)THIS INCIDENT IS REPORTABLE. THIS INCIDENT FALLS UNDER THE FDA PRESUMPTION THIS TYPE OF MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Description of Event or Problem · 1
IN 2009, A DOCTOR INFORMED ORMCO CORPORATION THAT HE HAD A DAMON CUNITI WIRE BREAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAMON COPPER NITI WIRE | WIRE, ORTHODONTIC | DZC | ORMCO CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |