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 2018-04-30 for X-STOP PEEK INTERSPINOUS SPACER 1-3210 manufactured by Medtronic Sofamor Danek Usa, Inc.
[106834546]
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
[106834547]
Pre-op diagnosis: lumbar spinal canal stenosis levels implanted: l4-l5 following was reported that on (b)(6) 2014 via a post market studay: (b)(6) 2012(day surgery), whether there were adverse events / malfunction during operation: none, adverse event 1: date of onset: (b)(6) 2014 adverse event / malfunction name: postoperative pain recurred, causal relationship with product: could not be denied, seriousness: serious, reoperation: yes (implant removal and laminectomy), other additional treatment: none outcome date: (b)(6) 2014, outcome: recovery, detailed information of adverse events / malfunction: (b)(6) 2014, right lower limb pain occurred suddenly. On (b)(6) 2014, it was confirmed that the position of the implant was abnormal by mri examination, and on (b)(6) 2014, implant removal and laminectomy were performed. Adverse event 2:date of onset: (b)(6) 2014 adverse event / malfunction name: implant was indwelt in an abnormal position, causal relationship with product: could not be denied, seriousness: serious, reoperation: yes (implant removal and laminectomy), other additional treatment: none outcome date: (b)(6) 2014, outcome: recovery, detailed information of adverse events / malfunction: (b)(6) 2014, right lower limb pain occurred suddenly. On (b)(6) 2014, it was confirmed that the position of the implant was anomaly by mri examination, and on (b)(6) 2014, implant removal and laminectomy were performed. Whether it was effective: ineffective, category of continuation / cancellation: cancellation, reason for discontinuation: surgical procedure associated with removing the product was required, and it became difficult to continue to investigate the safety and effectiveness of this product. Determination date of continuation /cancellation: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00622 |
| MDR Report Key | 7471725 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-30 |
| Date of Report | 2018-04-30 |
| Date of Event | 2014-09-20 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2011-02-15 |
| Date Added to Maude | 2018-04-30 |
| 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 USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-STOP PEEK INTERSPINOUS SPACER |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2018-04-30 |
| Model Number | NA |
| Catalog Number | 1-3210 |
| Lot Number | 2245341 |
| Device Expiration Date | 2013-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-04-30 |