MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-25 for CENTERPIECE SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[87197121]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event
Patient Sequence No: 1, Text Type: N, H10
[87197122]
It was reported that the patient underwent c4-6 expansive open-door laminoplasty due to cervical spondylotic myelopathy (csm). Post-op, infection /infection symptom was reported. The incision was irrigated and the irrigated incision was washed urgently on (b)(6) and after that, antibiotic was administered. The patient was under follow-up. Hospitalization was prolonged because revision surgery was performed to wash the irrigated incision. Increase of crp (c-reactive protein) level was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2017-02100 |
| MDR Report Key | 6889492 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-25 |
| Date of Report | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-09-25 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTERPIECE SPINAL SYSTEM |
| Generic Name | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
| Product Code | NQW |
| Date Received | 2017-09-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-25 |