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 |