MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-03-26 for X-STOP INTERSPINOUS SPACER SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[103424988]
Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103424989]
The event details listed below have been obtained from the cer (clinical evaluation report) "(b)(4)- cer for interspinous process devices- rev- 03 mar 2017" conducted from a data set from 2009 to 2015 which contained a multi literature article review. This could contain duplicated information obtained from other literature article. The complications associated with the ipds observed during review of literature articles published in different years as reported in the cer could be summarized as below: spinous process fracture was observed in 38 cases, revision surgery due to spinous process fracture in 10 cases, hematoma in 4 cases, wound infection in 18 cases, device removal/revision surgery in 100 cases, csf (cerebro-spinal fluid) leakage in 18 cases , new level stenosis in 1 case, pain (lss-lumbar spinal stenosis symptoms, back pain, leg pain) in 86 cases, revision surgery and device removal due to worsening pain in 1 case, revision suregry and device removal due to lack of improvement/ recurrence/persistence of symptoms in 20 cases and adjacent level fracture/fracture in 17 cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00448 |
| MDR Report Key | 7369308 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-26 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-26 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | X-STOP INTERSPINOUS SPACER SYSTEM |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2018-03-26 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2018-03-26 |