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 L18 TAN 04.210.118 manufactured by Synthes Monument.
[3098725]
A device report from (b)(6) indicated a hospital in (b)(6) reported: screws in unopened packages were taken from stock and it was noticed there were visible chips on all screw heads. There was no patient involvement. This is 6 of 6 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[10292667]
Device used for treatment and not diagnosis. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.
Patient Sequence No: 1, Text Type: N, H10
[17324314]
This device is used for treatment not diagnosis. The screw received is contained in a properly sealed synthes package with no evidence of tears or openings of any type. The printed label indicates that it contains a 04. 210. 118, lot number 6971717. Upon examination through the packaging with a 10x magnifier, chip wrap was found at the neck of the screw. The package was opened to allow further examination. No other burrs/chips were noted. Dhr was reviewed with no complaint related anomalies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2012-01433 |
| MDR Report Key | 2883320 |
| Report Source | 01,07 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-22 |
| Date Mfgr Received | 2013-01-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHERRY LAING |
| 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 L18 TAN |
| Generic Name | VA LOCKSCREW |
| Product Code | ODX |
| Date Received | 2012-12-21 |
| Returned To Mfg | 2012-12-10 |
| Catalog Number | 04.210.118 |
| Lot Number | 6971717 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 |