MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-10-22 for STREAMLINE MIS PEDICLE SCREW SYSTEM 05-PA-75-45 manufactured by Pioneer Surgical.
[15815729]
Patient was one week post op when he experienced numbness. It was determined that three of the screws in the pedicle screw constructs had disassociated. Patient was successfully revised with three new screws.
Patient Sequence No: 1, Text Type: D, B5
[15883208]
Explanted device was returned for inspection and was found to be within specifications. Device history record was reviewed and product was documented as being manufactured to pioneer surgical specifications. Upon further review of the films provided and conversations with the surgeon, it was determined that the screws were disassociated prior to the completion of the initial surgery but were not identified by the surgeon. The surgical technique guide was reviewed and a precaution notification was sent out of all users of this system in order to further emphasize precautions against surgical techniques that may have contributed to this occurrence. See mdr 1833824-2013-00018 for corresponding devices involved in this occurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1833824-2013-00019 |
| MDR Report Key | 3597672 |
| Report Source | 08 |
| Date Received | 2013-10-22 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-09-26 |
| Date Mfgr Received | 2013-09-25 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-03-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN NELSON, MGR |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE MI 49855 |
| Manufacturer Country | US |
| Manufacturer Postal | 49855 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STREAMLINE MIS PEDICLE SCREW SYSTEM |
| Generic Name | PEDICLE SCREW SYSTEM |
| Product Code | MCV |
| Date Received | 2013-10-22 |
| Returned To Mfg | 2013-10-01 |
| Model Number | 05-PA-75-45 |
| Catalog Number | 05-PA-75-45 |
| Lot Number | 150873 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PIONEER SURGICAL |
| Manufacturer Address | 375 RIVER PARK CIRCLE MARQUETTE MI 49855 US 49855 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-22 |