MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-01 for BOSTON KERATOPROSTHESIS TYPE I manufactured by Massachusetts Eye And Ear Infirmary.
[3143063]
Back plate fractured upon placement onto one front plate-cornea/donor complex. No patient involvement. Upon opening package and inspecting the boston keratoprosthesis, front plate and back plate were assembled- when inspecting front plate, small chip noted in optic with chip piece missing.
Patient Sequence No: 1, Text Type: D, B5
[10515105]
The broken back plate was confirmed on examination of the returned product. Pmma can fracture when struck directly. The instructions for the assembly call for pushing the locking ring onto the stem of the front plate to secure the back plate. If the back plate is struck directly by the assembly tool, it may fracture from the force of the hit. There was no patient involvement as the assembly is done prior to any patient contact with the device. It appears that during shipment or subsequent handling, the back plate slipped onto the stem of the front plate. The locking ring was not engaged, so the device was not truly assembled. A review of the packaging and assembly for boston keratoprosthesis was reviewed and the inspections of the components showed no indication of damage or chips. The packaging process requires two separate microscopic examinations of each component or debris or damage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222945-2013-00002 |
| MDR Report Key | 2971543 |
| Report Source | 05 |
| Date Received | 2013-02-01 |
| Date of Report | 2013-01-16 |
| Date of Event | 2012-12-18 |
| Date Mfgr Received | 2013-01-16 |
| Device Manufacturer Date | 2012-05-12 |
| Date Added to Maude | 2013-04-18 |
| 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 | LARISA GELFAND |
| Manufacturer Street | 243 CHARLES ST. |
| Manufacturer City | BOSTON MA 021143096 |
| Manufacturer Country | US |
| Manufacturer Postal | 021143096 |
| Manufacturer Phone | 6175734463 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON KERATOPROSTHESIS |
| Generic Name | KERATOPROSTHESIS |
| Product Code | HQM |
| Date Received | 2013-02-01 |
| Returned To Mfg | 2013-01-16 |
| Model Number | TYPE I |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASSACHUSETTS EYE AND EAR INFIRMARY |
| Manufacturer Address | 243 CHARLES ST. BOSTON MA 02114309 US 02114 3096 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-01 |