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 2020-01-31 for UNK - CAGE/SPACERS: PLIVIOS manufactured by Oberdorf Synthes Produktions Gmbh.
[177396725]
This report is for an unknown cage/spacers: plivios/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177396726]
This report is being filed after the review of the following journal article: lin gx, et al. (2019), time course observation of outcomes between minimally invasive transforaminal lumbar interbody fusion and posterior lumbar interbody fusion, neurol med chir (tokyo), volume 59, pages 222-230 (south korea). The purpose of our study is to compare patient outcomes, spinal fusion, and incidence of complications between mis-tlif and o-plif for comparison between mis-tlif and plif 223 neurol med chir (tokyo) 59, june, 2019 treatment of single-level lumbar spine pathology at a minimum of 5-year follow-up. From march 2010 to july 2013, 34 patients (mean age of 65. 4 +/-7. 6 years; range from 51 to 81 years) who underwent single-level minimally invasive transforaminal lumbar interbody fusion (mis-tlif) and 36 patients (mean age of 5. 8 +/- 0. 9 years; range from 5 to 8 years) who underwent single-level open posterior lumbar interbody fusion (o-plif) were included in the study. Patients in mis-tlif group were implanted with a single cage using either an unknown synthes opal cage or with competitors' devices. Meanwhile, patients in o-plif group were implanted with 2 cages using either an unknown synthes plivios cage, unknown synthes opal cage or competitors? Device. Patients were evaluated at 6-month, 2- and 5-year follow-up intervals. Complications were reported as follows: (mis-tlif group). 1 patient had dural tear and pulmonary thromboembolism and was referred to cardiology department. 1 patient had symptomatic screw malposition which required revision surgery. 1 patient had bone graft dislodgement. 4 patients had adjacent segment degeneration (asd), none of which required surgery. 2 patients had pseudoarthrosis. 10 patients had cage subsidence 5 years after surgery. Unknown patients had back pain. Unknown patients had leg pain. (o-plif group). 1 patient developed epidural hematoma, which required emergency surgical evacuation. 1 patient had asymptomatic osteolysis and was managed by observation alone. 12 patients had adjacent segment degeneration (asd). 4 of these patients required surgery to address clinical symptoms caused by asd. 1 patient underwent o-plif revision surgery, 2 patients underwent mis-tlif revision surgery (fig. 1), and 1 underwent minimally invasive discectomy (fig. 1) a (b)(6) female had an adjacent segment degeneration (asd). After 6 years, patient underwent revision with minimally invasive transforaminal interbody fusion at l3? 4 and minimally-access plif at l4? L5. 3 patients had pseudoarthrosis. 9 patients had cage subsidence 5 years after surgery. Unknown patients had back pain. Unknown patients had leg pain. This report is for the unknown synthes plivios cage. It captures the reported events of asymptomatic osteolysis, adjacent segment degeneration, pseudoarthrosis, epidural hematoma, back pain and leg pain. A copy of the literature article is being submitted with this medwatch. This is report 3 of 6 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-00769 |
| MDR Report Key | 9654139 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-31 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - CAGE/SPACERS: PLIVIOS |
| Generic Name | INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR |
| Product Code | OVD |
| Date Received | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |