MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-28 for UNK - CAGE/SPACERS manufactured by Wrights Lane Synthes Usa Products Llc.
[181548469]
There are multiple patients all information is provided in the article. This report is for an unknown cage/spacer/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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
[181548470]
This report is being filed after the review of the following journal article: wang, m. Y. And mummaneni, p. V. (2010), minimally invasive surgery for thoracolumbar spinal deformity: initial clinical experience with clinical and radiographic outcomes, neurosurgical focus, vol. 28 (3), pages 1-8 (usa). The aim of this retrospective study is to describe their initial experience with minimally invasive surgery for adult thoracolumbar spinal deformity. A total of 23 patients (6 male and 17 female) with a mean age of 64. 4 years (range 42? 84 years) underwent a lateral interbody fusion followed by posterior percutaneous screw fixation and possible minimally invasive surgical transforaminal lumbar interbody fusion if fusion near the lumbosacral junction was necessary. Surgery was performed by anterior approach using expandable cages (synthes spine or from a competitor) or femoral ring allograft, polyetheretherketone interbody cages from a competitor. Posterior supplemental fixation was performed with the use of viper percutaneous pedicle screws and connecting rods (depuy spine). The mean follow-up time was 13. 4 months (range 6? 34 months). The following complications were reported as follows: 84 out of 86 treated levels showed clear evidence of fusion, with no interbody pseudarthroses. 3 patients experienced minimal or no improvement in their symptoms. 1 patient had intraoperative pneumothorax due to exposure at t-12. A (b)(6)-year-old female patient had t-11 compression fracture 12 months postop, transient thigh numbness lateralized on the side of the anterolateral approach. A (b)(6)-year-old female patient had sacroiliac joint pain syndrome. An (b)(6)-year-old male patient had l5? S1 not clearly fused on ct, and transient thigh numbness & pain lateralized on the side of the anterolateral approach. A (b)(6)-year-old female patient had csf leak, new leg & thigh pain lateralized on the side of the anterolateral approach. A (b)(6)-year-old male patient developed atrial fibrillation (asymptomatic) postop day 3 which was treated with medical management. A (b)(6)-year-old female patient developed a pneumothorax that was not identified intraoperatively. This necessitated chest tube placement and a longer hospitalization (20 days). She also experienced sensory and motor changes that were severe and persistent enough to require use of an assistive device for ambulation. A (b)(6)-year-old male patient underwent partial corpectomies with a significant blood loss of 3500 ml. This was due to excessive bone bleeding during the partial corpectomies and was unrelated to any vascular injury. This patient required allogeneic blood transfusions. He also had pseudarthrosis at l1? 2 and proximal screw loosening, although the patient did not complain of any new symptoms. A (b)(6)-year-old female patient had transient thigh numbness and pain lateralized on the side of the anterolateral approach. A (b)(6)-year-old female patient had transient thigh numbness lateralized on the side of the anterolateral approach. A (b)(6)-year-old female patient had transient thigh numbness & pain lateralized on the side of the anterolateral approach. A (b)(6)-year-old female patient had persistent thigh pain & dysesthesias lateralized on the side of the anterolateral approach this report is for an unknown synthes cage. This report is for one (1) unknown cage/spacer. This is report 5 of 8 for (b)(4). This report is linked to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01101 |
| MDR Report Key | 9769178 |
| Report Source | LITERATURE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Generic Name | INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR |
| Product Code | OVD |
| Date Received | 2020-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |