MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-15 for 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM 401.043 manufactured by Oberdorf Synthes Produktions Gmbh.
[145388974]
Additional pro-code: jey. Occupation: synthes sales rep. A review of the device history record has been requested. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[145388975]
Device report from synthes reports an event in (b)(6) as follows: t was reported on (b)(6) 2019, during incoming goods checking, a titanium self-tapping cortex screw was noted to be missing in the sealed packaging. There was no patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-63990 |
| MDR Report Key | 8613539 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-07-12 |
| Device Manufacturer Date | 2018-07-26 |
| Date Added to Maude | 2019-05-15 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| 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 | 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM |
| Generic Name | SCREW FIXATION INTRAOSSEOUS |
| Product Code | DZL |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-05-06 |
| Catalog Number | 401.043 |
| Lot Number | H693487 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |