MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-25 for BIO-EYE UNK manufactured by Integrated Orbital Implants, Inc..
[17071941]
The report indicated that part of the orbital implant, sleeve, and peg had broken into pieces and there was conjunctival breakdown. The report additionally disclosed that culture of the pt indicated a mrsa infection and that the implant had been surgically removed. The implant was examined and found to have no vascularization.
Patient Sequence No: 1, Text Type: D, B5
[17231974]
The broken off section of the implant as well as the threaded sleeve and peg were returned for examination. Evaluation of the returned components indicated that the sleeve was placed asymmetrically within the orbital implant. This would have resulted in unbalanced radial forces and was likely contributory to the failure of the device. Subsequent conversation with the physician indicates that the explanted device was found to be devoid of vascularization - a condition not consistent with the requirement for full vascularization that would have been the case 10 years ago when the threaded sleeve was inserted into the orbital implant. In addition, it was noted that culture of the discharge indicated a mrsa infection. Consultation with the medical director indicates that a long-seated infection may be responsible for devascularization of the implant. It is unknown if the pt had a long-term infection or if the treating surgeon's hypothesis regarding the pt's heavy smoking were causal in the devascularization. It is hypothesized that the devascularization may have effectively weakened the orbital implant which was under stress from the mis-placed sleeve, ultimately causing the implant to fracture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2008-00001 |
| MDR Report Key | 1066047 |
| Report Source | 06 |
| Date Received | 2008-06-25 |
| Date of Report | 2008-06-23 |
| Date of Event | 2008-06-16 |
| Date Mfgr Received | 2008-06-23 |
| Date Added to Maude | 2008-07-03 |
| 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 | NATALIE KENNEL, CONSULTANT |
| Manufacturer Street | 13721 VIA TRES VISTA |
| Manufacturer City | SAN DIEGO CA 92129 |
| Manufacturer Country | US |
| Manufacturer Postal | 92129 |
| Manufacturer Phone | 8587050350 |
| Manufacturer G1 | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Street | 12625 HIGH BLUFF DR STE 314 |
| 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 | BIO-EYE |
| Generic Name | INTEGRATED ORBITAL IMPLANT |
| Product Code | HPZ |
| Date Received | 2008-06-25 |
| Returned To Mfg | 2008-06-19 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1035133 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-25 |