MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-15 for ESCALATE EXPANDABLE PLATE 48570300 manufactured by Stryker Spine-france.
[75322565]
It was reported that the plate pulled apart when expanding it. Pulled plate out and new plate was used
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2017-00203 |
| MDR Report Key | 6567967 |
| Date Received | 2017-05-15 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2016-11-24 |
| Date Added to Maude | 2017-05-15 |
| 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 | MS. CHRISTA MARROW |
| 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 | 0 |
| Brand Name | ESCALATE EXPANDABLE PLATE |
| Generic Name | SPINAL INTERLAMINAL FIXATION ORTHOSIS. |
| Product Code | NQW |
| Date Received | 2017-05-15 |
| Returned To Mfg | 2017-05-17 |
| Model Number | 48570300 |
| Catalog Number | 48570300 |
| Lot Number | 167503 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-FRANCE |
| Manufacturer Address | ZONE INDUSTRIELLE DE MARTICOT CESTAS 33610 FR 33610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-15 |