FDA Adverse Event
Injury
Summary report: N
COMBINED SUBMALAR SHELL-SMALL
MDR report key: 1509425
·
Received October 15, 2009
Report
- Report Number
- 2028924-2009-00005
- Event Type
- Injury
- Date Received
- October 15, 2009
- Date of Event
- April 15, 2009
- Report Date
- October 15, 2009
- Manufacturer
- IMPLANTECH ASSOCIATES, INC.
- Product Code
- LZK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: REVIEWED DEVICE HISTORY RECORDS, PRODUCT LABELING AND COMPLAINT RECORDS. RESULTS: DEVICE HISTORY RECORD REVIEW FOUND NO ASSIGNABLE CAUSE FOR REPORTED EVENT. A REVIEW OF COMPLAINT RECORDS INDICATES THERE HAVE BEEN NO OTHER COMPLAINTS ON THIS LOT. PRODUCT LABELING WARNS THAT "DISPLACEMENT OR SHIFTING OF THE IMPLANT CAN OCCUR FROM TOO LARGE A POCKET."
Description of Event or Problem · 1
COMPLAINANT REPORTED THAT LEFT SIDE MALAR IMPLANT WAS EXPLANTED 41 DAYS AFTER INITIAL PLACEMENT, DUE TO DISPLACEMENT/MIGRATION. THE DEVICE WAS REPLACED APPROX 5 MONTHS AFTER THE EXPLANT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMBINED SUBMALAR SHELL-SMALL | MALAR IMPLANT | LZK | IMPLANTECH ASSOCIATES, INC. | NA | 823880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |