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 2018-06-08 for X-STOP PEEK INTERSPINOUS SPACER 1-3210 manufactured by Medtronic Sofamor Danek Usa, Inc.
[110457662]
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
[110457663]
Levels implanted: l4-l5 followings were reported via a clinical study: date hospitalized, surgery date, date discharged: (b)(6) 2013, comments in case for the patient is still hospitalized, or discharge of the patient was delayed: there is no hospitalization/discharge from the hospital due to a day surgery. Name of adverse events/malfunction: dislocation of the implant. Cage 10mm, causality relationship between the event and could not be ruled out. Severity: serious. Additional surgery: removal of implant and laminectomy. Other additional treatment: none. Outcome date: (b)(6) 2015. Outcome: remission. Details of the adverse event or nonconformity: preoperative examination was performed on (b)(6) 2014. On (b)(6) 2014, implant was removed, and laminectomy was performed. Rehabilitation was performed at other hospital after discharge. Last visit to our hospital was on (b)(6) 2015. Comments for the adverse event or nonconformity: preoperative examination was performed on (b)(6) 2014. On (b)(6) 2014, implant was removed, and laminectomy was performed. Rehabilitation was performed at other hospital after discharge. Last visit to our hospital was on (b)(6) 2015. Type of end/withdrawal: withdrawal. Date determined of end/withdrawal (b)(6) 2015. Reason for withdrawal: surgical treatment associated with the removal of this product was necessary, and it became difficult to continue to investigate the safety and efficacy of this product. Efficacy evaluation: the treatment was not effective for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00822 |
| MDR Report Key | 7581770 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2014-07-22 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2018-06-08 |
| 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 | 2018-06-08 |
| Model Number | NA |
| Catalog Number | 1-3210 |
| Lot Number | RM12K009 |
| Device Expiration Date | 2014-12-21 |
| 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 | 2018-06-08 |