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 2017-01-23 for VERTECEM V+ SYRINGE KIT 03.702.215S manufactured by Synthes Selzach.
[65504852]
(b)(4). Device is an instrument and is not implanted / explanted. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. (b)(6). (b)(4). Device history records review was completed for part#: 03. 702. 215s, lot#: 6052681. Manufacturing location: (b)(4), manufacturing date: jul 26, 2016, expiry date: jun 01, 2021. No non conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[65504853]
Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that the cement of a vertecem v+ syringe kit was only enough for three injections and it ran out into patient? S body. The date of event was not provided. No information about patient outcome and surgical prolongation. This report is for one (1) vertecem v+ syringe kit. This is report 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000270450-2017-10019 |
| MDR Report Key | 6269722 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-23 |
| Date of Report | 2017-01-02 |
| Date Mfgr Received | 2017-01-02 |
| Device Manufacturer Date | 2016-07-26 |
| Date Added to Maude | 2017-01-23 |
| 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 | 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 | 2017-01-23 |
| Catalog Number | 03.702.215S |
| Lot Number | 6052681 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2017-01-23 |