MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for DSS STABILIZATION SYSTEM DPI56045 manufactured by Paradigm Spine Gmbh.
[90410835]
Dss revision surgery due to broken dss pedicle screw in s1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005725110-2017-00006 |
| MDR Report Key | 6947181 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2010-10-28 |
| Date Added to Maude | 2017-10-13 |
| 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. ALBERTO JURADO |
| Manufacturer Street | EISENBAHNSTRASSE 84 |
| Manufacturer City | WURMLINGEN, 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78573 |
| Manufacturer G1 | PARADIGM SPINE GMBH |
| Manufacturer Street | EISENBAHNSTRASSE 84 |
| Manufacturer City | WURMLINGEN, 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DSS STABILIZATION SYSTEM |
| Generic Name | POSTERIOR METAL / POLYMER SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2017-10-13 |
| Returned To Mfg | 2017-09-22 |
| Model Number | DPI56045 |
| Catalog Number | DPI56045 |
| Lot Number | 2010006098 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARADIGM SPINE GMBH |
| Manufacturer Address | EISENBAHNSTRASSE 84 WURMLINGEN, 78573 GM 78573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-13 |