MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for ESCALATE EXPANDABLE PLATE 48570300 manufactured by Stryker Spine-us.
[99223233]
It was reported that during a procedure, a plate was over expanded and came apart. The plate was taken out and replaced. There was a reported delay of 4/5 minutes. The procedure was completed successfully and there are no reports of adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2018-00034 |
| MDR Report Key | 7244905 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2017-02-24 |
| Date Added to Maude | 2018-02-06 |
| 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. MARTA KOUTSOGIANNIS |
| 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 ORTHOSI |
| Product Code | NQW |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2018-01-29 |
| Model Number | 48570300 |
| Catalog Number | 48570300 |
| Lot Number | 16A617 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-06 |