FDA Adverse Event
Injury
Summary report: N
COLLAPLUG
MDR report key: 3122086
·
Received May 16, 2013
Report
- Report Number
- 1121308-2013-00010
- Event Type
- Injury
- Date Received
- May 16, 2013
- Report Date
- May 16, 2013
- Manufacturer
- INTEGRA LIFESCIENCES CORP.
- Product Code
- LPG
- PMA / PMN Number
- P840062
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED "THE OFFICE HAD SEVERAL IMPLANT FAILURES AND REPORTS OF FEVER FROM THIS LOT OF COLLAPLUGS." NUMEROUS ATTEMPTS REQUESTING ADDITIONAL CLINICAL INFORMATION WERE MADE BY INTEGRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217187 | COLLAPLUG | DENTAL PRODUCTS | LPG | INTEGRA LIFESCIENCES CORP. | 1110240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |