MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-05-23 for W-H ELEV DIAMOND HEAD 3/4 202918 manufactured by Depuy Synthes Spine.
[75767986]
Udi: (b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[75767987]
Voluntary event report from fda ( mw5068895) a male patient underwent an anterior lumbar interbody fusion l4-l5 and l5-s1 levels. During surgery, a diamond cobb elevator was being used and while maneuvering the instrument, it broke in half with a residual part remaining in the disc space. The remaining piece was removed by the surgeon and upon removal, the left common iliac vein and left external iliac vein were lacerated. This warranted a surgical intervention by a vascular surgeon for repair of both lacerated veins. Post repair, bleeding was under control and orthopedic surgeon proceeded with completion of the intended orthopedic procedure. Patient had one unit of packed cells in recovery. On (unk date 2017), patient was stable and discharded home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2017-10387 |
| MDR Report Key | 6584418 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-05-23 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-04-25 |
| Date Added to Maude | 2017-05-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | W-H ELEV DIAMOND HEAD 3/4 |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-05-23 |
| Catalog Number | 202918 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-05-23 |