MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-05-06 for USS LOWPROFILE PEDICSCREW ?7 SIDE-OPEN L 499.142 manufactured by Synthes Gmbh.
[17460027]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the screws were wrongly etched. The screws were marked as 4. 2mm, when in actuality they are 7 millimeters. This report is for a uss low profile pedicle screw, 7mm side-open. This is 1 of 1 devices for this event reported on complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17742861]
Device was used for treatment, not diagnosis. Device is not distributed in the united states, but is similar to device marketed in the usa. An additional evaluation was conducted by synthes (b)(4) and the report indicates: the investigation showed the etching did not conform to specifications. It was confirmed the diameter of the pedicle screw was etched as 4. 2mm, instead of 7mm and it was determined the screw was manufactured from a lot dating back to july 2008. Further, although other devices from the same lot where also released during the final inspection, there have not been any reports of any events involving these devices. Also, a review of the device history records (dhr) was performed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-02105 |
| MDR Report Key | 3093577 |
| Report Source | 01,07 |
| Date Received | 2013-05-06 |
| Date of Report | 2009-04-23 |
| Date Mfgr Received | 2009-04-23 |
| Device Manufacturer Date | 2008-07-17 |
| Date Added to Maude | 2013-07-12 |
| 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 | NEIL PATEL |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USS LOWPROFILE PEDICSCREW ?7 SIDE-OPEN L |
| Product Code | MCV |
| Date Received | 2013-05-06 |
| Returned To Mfg | 2009-04-27 |
| Catalog Number | 499.142 |
| Lot Number | 2390589 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-06 |