MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-28 for UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES manufactured by Medos International Sàrl Ch.
[187735988]
This report is for an unknown screw/rod construct accessories/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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
[187735989]
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. 1 case, who had a posterolateral (without interbody) fusion at the thoracolumbar junction, did not demonstrate radiographic fusion which resulted to asymptomatic screw loosening at the 9-month follow-up. A (b)(6)-year-old female patient had s-1 screw pullout on postoperative day 34 which required a return to the operating room to extend the construct to the ilium. 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. This report is for an unknown depuy spine viper. This is report 3 of 8 for (b)(4). The complaint involves 12 devices. Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4): this complaint will include 10 devices - 7 unknown screw/rod construct, 1 unknown rods, 2 unknown mono/polyaxial screws (1st pc). (b)(4): this complaint will include 2 devices - 1 unknown rods, 1 unknown mono/polyaxial screws (2nd pc). This complaint is also linked to depuy synthes complaints under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00627 |
| MDR Report Key | 9769898 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES |
| Generic Name | ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION |
| Product Code | MNH |
| 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 | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |