MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

G5 ¿ 510k: 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).

Event Description

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) female patient had t-11 compression fracture 12 months postop, transient thigh numbness lateralized on the side of the anterolateral approach.A (b)(6) female patient had sacroiliac joint pain syndrome.An (b)(6) 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) female patient had csf leak, new leg & thigh pain lateralized on the side of the anterolateral approach.A (b)(6) male patient developed atrial fibrillation (asymptomatic) postop day 3 which was treated with medical management.A (b)(6) 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) 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) 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 1 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) and (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9769877
• MDR Text Key: 190911152
• Report Number: 1526439-2020-00625
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR