FDA Adverse Event
Malfunction
Summary report: N
DAMON COPPER NITI WIRE
MDR report key: 1000825
·
Received February 21, 2008
Report
- Report Number
- 2016150-2008-00012
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- February 8, 2008
- Manufacturer
- ORMCO CORP.
- Product Code
- DZC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 FEBRUARY 2008, A DR INFORMED ORMCO CORPORATION THAT HE HAD DAMON CUNITI WIRE BREAKAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAMON COPPER NITI WIRE | WIRE, ORTHODONTIC | DZC | ORMCO CORP. | 07E160E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |