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 2017-06-13 for CEMENT DISPENSER manufactured by Synthes (usa).
[77428812]
Patient identifier and weight are not available for reporting. This report is for an unknown vertecem v+ kit. Part and lot numbers are unknown; udi number is unknown. Device was not explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). Without a lot number the device history records review could not be completed. 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
[77428813]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported during cementing of depuy spine cfx screws with vertecem v+ on (b)(6) 2017, the (b)(6) patient expired. The indication of surgery was possibly a vertebral fracture at l1 or t12. Vertecem v+ was augmented in four (4) vertebral body; approximately 10 ml. Leakage outside the vertebral body was not noted. At this time, there is no noted cement-related embolism. Cause of death is unknown, potentially myocardium collapse/weakness. It is unknown if an autopsy was performed and the post-mortem report and x-rays are not available. Medical safety officer review of this event determined the patient featured in this complaint was subject to the collective risks of advanced age, the procedure performed, concomitant fixation products and the unspecified indication for the procedure. These risks are likely significant contributors to the patient outcome in this complaint. However, although there is no explicit allegation that vertecem v+ caused or contributed to this fatality, because of the established risks of vertecem v+, there is a potential causal relationship between vertecem v+ and this patient outcome. Concomitant devices reported: cfx screw (quantity 1). This report is for one (1) unknown vertecem v+ kit. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[86894442]
An investigation summary was performed. The investigation of the complaint articles has shown that: information received; the event occurred on (b)(6) 2017. The indication of surgery was possibly vertebral fracture l1 or t12. Vertecem was augmented in 4 vertebral body with approximately 10ml. The sales rep did not seen leakage to outside of the vertebral body. At this time, there is no noted cement-related embolism. The cause of death is unknown, potentially myocardium collapse/weakness. The reportability determination will remain reportable. Should additional information become available, this determination should be reassessed. No article and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. No investigation possible due to the lack of information. No product received for evaluation, no further information available. 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
| Report Number | 2520274-2017-11792 |
| MDR Report Key | 6636706 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-08-10 |
| Date Added to Maude | 2017-06-13 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CEMENT DISPENSER |
| Product Code | OAR |
| Date Received | 2017-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-06-13 |