MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-29 for SCOUT VESSEL GUARD 65MM X 110MM X 1MM-STERILE 08.650.102S manufactured by Synthes (usa).
[3432659]
Consultant reported: during an anterior lumbar interbody fusion (l4-s1) procedure, the corner of the scout vessel guard ripped after the suture was placed. The other three (3) corners were okay. Surgeon left the scout vessel guard in place. Procedure was completed with no further problem. This is 1 of 1 reports for this event, complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10696929]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of the device history records was performed and no complaint related issues were found. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
[11456170]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Original awareness date is (b)(4) 2011. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[23272225]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-11192 |
| MDR Report Key | 3081838 |
| Report Source | 05,07 |
| Date Received | 2013-04-29 |
| Date of Report | 2011-11-17 |
| Date of Event | 2011-11-17 |
| Date Mfgr Received | 2014-05-20 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2013-07-02 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOUT VESSEL GUARD 65MM X 110MM X 1MM-STERILE |
| Product Code | OMR |
| Date Received | 2013-04-29 |
| Catalog Number | 08.650.102S |
| Lot Number | N002929 |
| Device Expiration Date | 2012-01-31 |
| 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 | 2013-04-29 |