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 2019-03-01 for VERTECEM V+ SYRINGE KIT 03.702.215S manufactured by Oberdorf Synthes Produktions Gmbh.
[137541557]
The device was received, the investigation is in progress, 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
[137541558]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an unknown procedure, two (2) vertecem syringe kits were bent and broken after removing from the vertecem cement kit reservoir. It was not possible anymore to attach the syringes to the standard luer needle since the tip of the syringe screw got bent and broke. The procedure was successfully completed by using other syringes that were still good. No surgical delay and no patient consequence reported. Concomitant device reported: unknown vertecem cement kit (part # 07. 702. 016s, lot# unknown, quantity 1). This report is for one (1) vertecem v+ syringe kit. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-61627 |
| MDR Report Key | 8381868 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2018-12-16 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 | 2019-03-01 |
| Returned To Mfg | 2019-02-12 |
| Catalog Number | 03.702.215S |
| Lot Number | 8102588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-01 |