MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-21 for VA LOCKSCR ?2.4 SELF-TAP L12 TAN 04.210.112 manufactured by Synthes Monument.
[10561797]
This device is used for treatment, not diagnosis. Dhr was reviewed with no complaint related anomalies noted.
Patient Sequence No: 1, Text Type: N, H10
[19575019]
Device was used for treatment, not diagnosis. The investigation is ongoing; no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[19694729]
Device report from synthes (b)(6) reports an event in (b)(6) as follows. It was reported that there were visible chips on the screw head. The screw was noted to be in an unopened package taken from stock. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[22203803]
Device used for treatment and not diagnosis. One screw was received with the task associated with this complaint. This screw is packaged in a synthes (b)(4) market type bag. The package was properly sealed with no tears or openings of any kind. It is identified as part number 04. 210. 112, lot number 6818859. The part was first examined under 10 x magnifications through the sealed bag. Chip wrap was found in the neck area of the screw. The package was then opened to further examine the sample. No other burrs/anomalies were found. The chip wrap can be seen with the naked eye.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2012-01425 |
| MDR Report Key | 2883691 |
| Report Source | 01,07 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-22 |
| Date Mfgr Received | 2013-02-01 |
| Date Added to Maude | 2013-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY BROWN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VA LOCKSCR ?2.4 SELF-TAP L12 TAN |
| Generic Name | VA LOCKSCR ?2.4 SELF-TAP L12 TAN |
| Product Code | DYX |
| Date Received | 2012-12-21 |
| Returned To Mfg | 2012-12-10 |
| Catalog Number | 04.210.112 |
| Lot Number | 6818859 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-21 |