MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,07 report with the FDA on 2015-01-06 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes Usa.
[22159427]
This report is being filed after the subsequent review of the following literature: lammli, j. , et al (2014). Stand-alone anterior lumbar interbody fusion for degenerative disc disease of the lumbar spine. Spine, 39, 894-897. A retrospective chart review was conducted to report outcomes of a consecutive series of patients diagnosed with degenerative disc disease (ddd) between l4 and s1, treated with stand-alone anterior lumbar interbody fusion and use of recombinant human bone morphogenetic protein 2 for bony fusion with instrumented fixation. A total of 118 patients who met inclusion/exclusion criteria were included in the final analysis. More than half (58. 5%) of the patients were females. Average age was 43? 10 years at the time of surgery. Most patients (91. 5%) were caucasians and nonsmokers (50. 0%); although, half of the patients were either former or current smokers prior to surgery. Researchers reviewed a consecutive series of patients with ddd who had undergone a 1-level or 2-level alif between 2005 and 2010, with the use of recombinant human bone morphogenetic protein 2. Patients? Clinical and functional outcomes were documented. Radiographs were analyzed for disc height, mean optical density, and integrated optical density. Operative time, length of hospital stay, and estimated blood loss were also reported. Once the discectomy and endplates had been prepared, the surgeon proceeded with cage replacement and spinal fusion using any of the following stabilization instrumentation: an anterior plate with 4 screws (atb plate), an integrated cage/plate device with 4 screws (synfix-lr), and/or an interbody cage/spacer (either peek cage, or bp lordotic cage, ar spacer, or femoral ring allografts (fra). One or 2 sponges of rhbmp-2 and autograft was used during each procedure. Eight (8) patients were not fused 2 years postoperatively (2 maintained function and 4 experienced improved function). No patient experienced intraoperative or major complications (e. G. , death/neurological damage). Postoperatively, 2 patients were treated for hematomas. No patients reported significant pain associated with sexual activities after surgery not already present prior to fusion. Nine patients reported that the pain continued after surgery. Nine patients underwent additional surgical procedures: 3 had operations not related to the adjacent level or the fusion site, 3 had operations related to degeneration that occurred at the level adjacent to fusion, and 3 experienced pseudarthrosis at the fusion level, and underwent revision surgery (1 alif, 2 posterior spinal fusion). Patients' 2-year oswestry disability index and visual analogue scale presurgery scores significantly improved (p = 0. 0001). Patients? 2-year postoperative disc height was significantly greater than the preoperative disc height at the fused level (p = 0. 0001); there was no significant difference at the level adjacent to fusion. The majority of patients (107 of 115, 93. 0%) satisfied fusion criteria based on mean optical density. This report is against an unknown number of peek cages regarding non-unions, pain, hematomas, adjacent level disease, and pseudarthrosis. This report 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22269838]
The device was used for treatment, not diagnosis. Lammli, j. , et al (2014). Stand-alone anterior lumbar interbody fusion for degenerative disc disease of the lumbar spine. Spine, 39, 894-897. This report is for unknown peek cage devices/unknown quantity/unknown lot number. Adjacent level disc disease. The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-10054 |
| MDR Report Key | 4384391 |
| Report Source | 03,07 |
| Date Received | 2015-01-06 |
| Date of Report | 2014-12-10 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-01-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2015-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-06 |