MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-02 for SPINTEK OPENING INSTRUMENT 866-4014 manufactured by Ormco Corporation.
[37737173]
Ormco corporation was notified on january 22, 2016 by the competent authority of the (b)(6) that a complaint had been registered with regard to the ormco spintek instrument. The competent authority had been notified by an end user on august 14, 2015 that sterilization instructions had not been provided for the product. The end user stated that the parts could not be cleaned, processed, and reused until a cleaning process for the instrument had been approved. No serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: N, H10
[37737174]
Unable to supply confirmation of sterilization and decontamination on instruments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2016-00023 |
| MDR Report Key | 5404627 |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-22 |
| Date Mfgr Received | 2016-01-22 |
| Date Added to Maude | 2016-02-02 |
| 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 | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPINTEK OPENING INSTRUMENT |
| Generic Name | SPINTEK OPENING INSTRUMENT |
| Product Code | JEX |
| Date Received | 2016-02-02 |
| Catalog Number | 866-4014 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-02 |