MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-02 for BOSTON KERATOPROSTHESIS TYPE I manufactured by Massachusetts Eye And Ear Infirmary.
[3327191]
Boston keratoprosthesis was assembled by the cornea fellow in training while the attending doctor removed the pt's cornea. While attempting to use the locking pin to lock the titanium ring over the back plate, the tool was improperly positioned over the ring. When downward pressure was applied, the tool was not perfectly perpendicular and caused a fracture of the back plate. Since the host cornea was already removed, the doctor decided to suture the graft - prosthetic combination without back plate as a temporary measure. The next day, the doctor contacted boston keratoprosthesis and following the advice of boston kpro, he successfully completed the surgery with a new back plate and titanium ring 2 days later.
Patient Sequence No: 1, Text Type: D, B5
[10597960]
The broken back plate was confirmed on the examination of the returned product. The instructions for assembly of the kpro call for pushing the locking ring down into the groove with the assembly pin at 90 degrees from the front plate. The breakage can occur if the tool is not perfectly perpendicular and it hits the back plate. The instructions clearly indicate, that the graft-prosthetic combination after the inspection under the microscope has to be removed from the adhesive and stored in the eye bank solution while the pt's eye is prepared. The assembly was performed by an inexperienced assistant, but the pt's cornea was already removed and the doctor decided to suture the graft-prosthetic combination into the pt's eye as a temporary measure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222945-2013-00003 |
| MDR Report Key | 3038263 |
| Report Source | 05 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-03-15 |
| Date of Event | 2013-03-04 |
| Date Mfgr Received | 2013-03-15 |
| Device Manufacturer Date | 2012-08-29 |
| Date Added to Maude | 2013-05-31 |
| 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 | 2013-04-02 |
| Returned To Mfg | 2013-03-15 |
| Model Number | TYPE I |
| Lot Number | BP091812; LR-082212 |
| ID Number | ASS.TOOLLOT#072612 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-04-02 |