MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-21 for APPLEBAUM INCUDO-STAPEDIAL ,SM,HA 140956 manufactured by Osta.
[70522981]
As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The implant device has not been returned to olympus for evaluation. The cause of the reported event could not be determined at this time; however, user handling and operator? S technique could not be ruled out as contributory factors to the reported event. The instruction manual for use states,? 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
[70522982]
Olympus was informed that during an unspecified ear implant procedure, the implant device broke apart inside the patient. All broken pieces were retrieved. The procedure was completed using a different but similar implant device. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[78989624]
The device was returned to olympus for evaluation. The evaluation confirmed the reported device damage. A visual inspection under a microscope found the implant device broken off on one side. The broken piece was not returned to olympus. The device fragment measured approximately 1mm in length. This type of device is fragile and should be handled with care. If handled with excessive force, device damage could result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2017-00175 |
| MDR Report Key | 6423379 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-21 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-02-16 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-03-21 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLEBAUM INCUDO-STAPEDIAL ,SM,HA |
| Generic Name | APPLEBAUM INCUDO-STAPEDIAL ,SM,HA |
| Product Code | ETB |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2017-05-01 |
| Model Number | 140956 |
| Catalog Number | 140956 |
| Lot Number | MH597751 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| 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 MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |