FDA Adverse Event
Injury
Summary report: N
NONE
MDR report key: 1880236
·
Received October 19, 2010
Report
- Report Number
- 1526439-2010-00150
- Event Type
- Injury
- Date Received
- October 19, 2010
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- LYC
- PMA / PMN Number
- K081432
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOUND NO DISCREPANCIES OR NONCONFORMANCES DURING PRODUCTION. EVENTS OF THIS NATURE ARE AN INHERENT RISK OF THE PROCEDURE AND AS REPORTED THIS DOES NOT APPEAR TO HAVE BEEN DEVICE RELATED.
Description of Event or Problem · 1
PERIODONTIST REPORTED THAT HE USED HEALOS DENTAL FOR A SINUS ELEVATION PROCEDURE. APPROX 1-WEEK OUT, THE PATIENT HAD RETURNED WITH A LOCALIZED INFECTION (GREEN DISCHARGE). HE OPENED THE SITE AND CLEANED AND DRAINED THE AFFECTED AREA. THE HEALOS WAS GRANULAR AND HE REMOVED IT FROM THE SITE. HE REPORTED THAT THE INFECTION RESOLVED AFTER TREATMENT. AS INTERVENTION WAS REQUIRED, AN MDR IS FILED TO DOCUMENT THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | LYC | DEPUY SPINE, INC. | NA | 10F0028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |