MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-29 for SPINEOLOGY OPTIMESH TRAY 3110100 manufactured by Spineology, Inc..
[4071010]
During set-up in operating room for a minimally invasive spine procedure, debris was found on operating room table. Debris came out of an instrument from a vendor loaned set. Room was cleaned. New supplies and instrumentation was obtained. The three pieces of equipment were removed from service and returned to vendor since it was loaned equipment. Another tray was set up for the case that did not have any visible debris. As part of investigation, a sterile tray was examined and debris was found after manipulating the equipment. This may be a problem with the design of the equipment that will not allow you to take it apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034122 |
| MDR Report Key | 3603245 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-24 |
| Date of Event | 2014-01-09 |
| Date Added to Maude | 2014-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINEOLOGY OPTIMESH TRAY |
| Generic Name | INSERTER ARTICULATING CURETTE |
| Product Code | GZX |
| Date Received | 2014-01-29 |
| Model Number | 3110100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET NORTH STE 600 ST PAUL MN 55128545 US 55128 5455 |
| Brand Name | SPINEOLOGY OPTIMESH TRAY |
| Generic Name | ELOCKING MESH HOLDER |
| Product Code | GZX |
| Date Received | 2014-01-29 |
| Model Number | 311088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET NORTH STE 600 ST PAUL MN 55128545 US 55128 5455 |
| Brand Name | SPINEOLOGY OPTIMESH TRAY |
| Generic Name | 6.5MM SHAPER |
| Product Code | GZX |
| Date Received | 2014-01-29 |
| Model Number | 3110042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET NORTH STE. 600 ST PAUL MN 55128545 US 55128 5455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-29 |