MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for VLIFT CAGE DIAM 18 X 25MM 48291825 manufactured by Stryker Spine-us.
[184154544]
Device remains implanted in patient.
Patient Sequence No: 1, Text Type: N, H10
[184154545]
It was reported that a vlift cage securing mechanism disengaged post-operatively. There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay. There are no plans for revision surgery at this time as the clinical outcome is sufficient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2020-00020 |
| MDR Report Key | 9700728 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-12 |
| 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 | MR. RITA KARAN |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER SPINE-FRANCE |
| Manufacturer Street | ZONE INDUSTRIELLE DE MARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VLIFT CAGE DIAM 18 X 25MM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-12 |
| Model Number | 48291825 |
| Catalog Number | 48291825 |
| Lot Number | 190784 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-US |
| Manufacturer Address | 2 PEARL COURT ALLENDALE NJ 07401 US 07401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |