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 2019-03-04 for VERTECEM V+ SYRINGE KIT 03.702.215S manufactured by Oberdorf Synthes Produktions Gmbh.
[137827867]
Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. 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
[137827868]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the tip of the white vertecem syringe kit broke while removing from cement reservoir (vercetem v+ cement kit) during an unknown procedure. The surgical procedure was successfully completed although it is unknown how was the procedure completed. There were no surgical delay and patient consequence reported. Concomitant device reported: vercetem v+cement kit (part# 07. 702. 016s, lot# unknown, quantity 1). 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 | 8030965-2019-61711 |
| MDR Report Key | 8387978 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-04 |
| Date of Report | 2019-02-11 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2018-12-16 |
| Date Added to Maude | 2019-03-04 |
| 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 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECEM V+ SYRINGE KIT |
| Generic Name | CEMENT DISPENSER |
| Product Code | OAR |
| Date Received | 2019-03-04 |
| Catalog Number | 03.702.215S |
| Lot Number | 8102588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-04 |