MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-26 for ALPHASPHERE ORBITAL IMPLANT AS-22 manufactured by Addition Technology.
[18840881]
Pt presented for f/u one month subsequent to the insertion of an orbital implant. The orbital implant was inserted after enucleation of the eye for choroidal melanoma. The pt was found to have conjunctival dehiscence over the implant. The pt was initially returned to the operating room for conjunctival repair instead of implant exchange. The wound was explored. The mesh connecting the two hemispheres of the device was found to be very friable and the muscles were no longer attached to the implant despite attempts made during the primary procedure to ensure suturing to the mesh. The capsule around the implant was submitted for pathology and revealed foreign body giant cell reaction.
Patient Sequence No: 1, Text Type: D, B5
[18987439]
It is unclear why this unit was rejected by the pt. Typically, alphasphere units biointegrate with the pt's muscles without issue. This is the first complaint of this type and since there is only one data point and no unit to examine, no conclusions can reliable be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005344923-2011-00001 |
| MDR Report Key | 2115161 |
| Report Source | 05 |
| Date Received | 2011-05-26 |
| Date of Report | 2011-05-25 |
| Date of Event | 2011-04-08 |
| Date Mfgr Received | 2011-04-29 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2011-06-13 |
| 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 Street | 950 LEE STREET SUITE 210 |
| Manufacturer City | DES PLAINES IL 60016 |
| Manufacturer Country | US |
| Manufacturer Postal | 60016 |
| Manufacturer Phone | 8472978651 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHASPHERE ORBITAL IMPLANT |
| Generic Name | 886.3320 - HPZ |
| Product Code | HPZ |
| Date Received | 2011-05-26 |
| Model Number | AS-22 |
| Lot Number | AS-134-10B |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADDITION TECHNOLOGY |
| Manufacturer Address | 950 LEE STREET SUITE 210 DES PLAINES IL 60016 US 60016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-26 |