MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-25 for DE LA CRUZ PISTON .6 X 4. 70140733 manufactured by Osta.
[41217811]
No device was returned to olympus for evaluation. The cause of the reported event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[41217812]
Olympus was informed that during a therapeutic right revision stapedotomy procedure, the patient presented to the clinic due to significant decrease in hearing over a year. At the beginning of the surgery, a de la cruz piston was noted to be fractured at the shepard's crook. The fracture did not occur during the surgery. It happened sometime after it was implanted in 2004. The implant was reported to have fragmented inside of the patient's ear. All the pieces were removed during the subsequent surgery on (b)(6) 2016. According to the surgeon, after the procedure and upon inspection of the incus and the piston prosthesis, it was noted that there was significant erosion of the distal aspect of the incus and there was a fracture of the prosthesis itself at the shepherd's crook. The prosthesis was easily removed in two pieces by lasering the mucosa at the level of the footplate to assist in removal. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[45859420]
This supplemental submission corrects the report type and reportable event type from a serious injury to a malfunction as the facility reported there was no patient injury associated with the report.
Patient Sequence No: 1, Text Type: N, H10
[55600398]
This supplemental report is being submitted to provide the device evaluation results. The broken device was returned to olympus for evaluation. A visual and microscope inspection revealed biomaterial adhered on the device, and there is deformation on the white plastic part with stains. Additionally, the two broken pieces were measured in length with the long portion at 5. 5mm, and the small portion at 1. 5mm. (per olympus reference guide, the piston functional length standard is 4. 25mm). The shaft was also found to be bent and twisted. Based on the investigation findings, the most likely cause of the device damage can be attributed to manipulation, or sizing with excessive stress on the head and shaft causing the device to break apart. The instruction manual warns users: "as all prostheses are inherently delicate and some materials, such as hydroxylapatite, are brittle in nature, careful handling is essential to prevent damage during manipulation, trimming or sizing, and implantation. All trimming or sizing should be performed on a cutting block with only the shaft resting on the surface of the cutting block so as not to place excessive stress on the head and shaft interface.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2016-00331 |
| MDR Report Key | 5527455 |
| Date Received | 2016-03-25 |
| Date of Report | 2016-09-15 |
| Date of Event | 2016-02-10 |
| Date Mfgr Received | 2016-09-09 |
| Date Added to Maude | 2016-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DE LA CRUZ PISTON .6 X 4. |
| Generic Name | DE LA CRUZ PISTON |
| Product Code | ETB |
| Date Received | 2016-03-25 |
| Returned To Mfg | 2016-09-08 |
| Model Number | 70140733 |
| Catalog Number | 70140733 |
| Lot Number | 0348516503 |
| ID Number | UDI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-25 |