D
Patient 1
PHYSICIAN'S OFFICE REPORTED THAT THE DOCTOR IMPLANTED A 20MM STERILE IMPLANT. THE PT NOW HAS AN "EXPOSED" IMPLANT. PT RETURNED TO SURGERY FOR REMOVAL OF IMPLANT IN 2007.
MAUDE MDR 974756
- MDR report key
- 974756
- Report number
- 2027377-2007-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-11-16
- Date received
- 2008-01-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NATALIE KENNEL, CONSULTANT
- Phone
- 858-858-8582
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIO-EYE | IMPLANT, EYE SPHERE | INTEGRATED ORBITAL IMPLANTS, INC. | HPZ | I00020S | I00020S | 198037 | N | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-01-02 | 0 | 1. R |
Event Narratives#
N
Patient 1
EXPOSURES ARE AN ANTICIPATED POSSIBLE COMPLICATION WITH THIS TYPE OF SURGERY. A REVIEW OF THE LITERATURE FINDS EXPOSURE RATES RANGING FROM 2.5% TO 21.6%. DISCUSSION OF THESE CASES WITH THE REPORTING PHYSICIAN SUGGESTS A CORRELATION WITH CHANGES IN THE CLINIC'S WRAPPING PRACTICES. IT IS UNKNOWN WHETHER THERE IS A CAUSAL RELATIONSHIP. WE ARE ANTICIPATING THE RETURN OF THE EXPLANTED DEVICES FOR FURTHER INVESTIGATION.