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 2017-05-26 for VERTECEM V+ SYRINGE KIT 03.702.215S manufactured by Synthes Selzach.
[76154910]
Device used for treatment, not diagnosis. Patient information not available for reporting. Other udi: (b)(4). Implant and explant dates: device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Initial reporters phone number: (b)(6). Device history records review was conducted. The report indicates that the: 03. 702. 215s / 6072679 manufacturing location: (b)(4). Supplier: symatese device manufacturing date: 28 oct 2016, expiry date: 01 oct 2021. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[76154911]
Device report from synthes on an event in (b)(6) as follows: it was reported that during surgery while filling the cement into the white 2cc syringes, the stamps of the syringes backed out of the outer tube, the stop was not working. All syringes had the same problem. There was no patient harm and the outcome was fine. The surgery was not prolonged and was successfully completed. This complaint involves 1 part. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000270450-2017-10183 |
| MDR Report Key | 6595414 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-06 |
| Date of Event | 2017-05-06 |
| Date Mfgr Received | 2017-07-21 |
| Device Manufacturer Date | 2016-10-28 |
| Date Added to Maude | 2017-05-26 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHNACKERWEG 5 |
| Manufacturer City | SELZACH CH2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2545 |
| 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 | 2017-05-26 |
| Catalog Number | 03.702.215S |
| Lot Number | 6072679 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES SELZACH |
| Manufacturer Address | BOHNACKERWEG 5 SELZACH CH2545 SZ CH2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-26 |