MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-07 for COATED BIO-EYE HA IMPLANT WITH CONFORMER manufactured by Integrated Orbital Implants.
[783886]
Dr. Reported that patient was implanted with coated bio-eye two years earlier and that patient was currently experiencing an exposure of the implant and its anterior shell.
Patient Sequence No: 1, Text Type: D, B5
[7897089]
Exposure is an anticipated complication of orbital implant surgery. It is generally treated conservatively and is surgically closed only in the case of large exposures or if the wound does not spontaneously close within a reasonable time period. The anterior shell of the coated bio-eye implant is designed to resorb in 12-15 months. It's presence visible through the exposure at 24 months is therefore reported as a malfunction. Dissolution rates of bioresorbable polymers is dependant upon a number of characteristics including temperature and hydration, and is anticipated to vary based upon the individual patient's physiology. In the event that the exposure was of prolonged duration the polymer would not be hydrated, and therefore not subject to the designed rate of degradation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2007-00001 |
| MDR Report Key | 961321 |
| Report Source | 05 |
| Date Received | 2007-12-07 |
| Date of Report | 2007-02-17 |
| Date of Event | 2007-02-17 |
| Date Mfgr Received | 2007-02-17 |
| Date Added to Maude | 2007-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WATALIE KENNEL, CONSULTANT |
| Manufacturer Phone | 8582594355 |
| Manufacturer G1 | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Street | 12625 HIGH BLUFF DR. |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COATED BIO-EYE HA IMPLANT WITH CONFORMER |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2007-12-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 932886 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-07 |