MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws (viper sc screw)/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.

Event Description

This report is being filed after the review of the following journal article: george, a.A., a peek rod based dynamic instrumentation construct for the lumbar spine, first appraisal based on five year clinical and radiological findings, pages 1¿10 (germany).The aim of this retrospective single arm study is to assess the five-year results of a novel pedicle screw and rod-based construct consisting of regular viper and viper sc screws from depuy synthes combined with peek rods.Between january 2011 to december 2012, a total of 100 patients (44 male and 56 female) with an average age of 68 years were included in the study.Surgery was performed using the pedicle based dynamic instrumentation system consists of viper and viper semi-constrained (sc) screws as well as polyetheretherketone (peek) rods 5,5 mm in diameter with lordotic bend.The average follow-up was 58 months with a maximum of 96 months and a minimum of 12 months.The following complications were reported as follows: intraoperative.13 patients had a dura lesion, 3 in a one-segment surgery, 8 in a two-segment surgery and 2 in a three and more segment instrumentation.2 screw malposition was observed.Postoperative.33 patients required further surgery.In the early postoperative period (3 months) there were 9 patients, 3 was due to wound dehiscence, 1 due to a symptomatic screw malposition, 2 due to hematoma and 3 because of persistent stenosis.The rest of 24 had required further surgery up to 6 years postoperatively.14 patients because of a symptomatic screw loosening or breakage, 1 had developed a metastasis and had the implants removed in order to facilitate radiotherapy, 9 patients required further surgery because of symptomatic in segment restenosis, herniated disc or asp.2 screw malposition were also recorded which were all revised.In the case of the 53 patients having received a one segment instrumentation the rate of radiological asp was noted as 24 (45 %) at an average of 69 months.Out of the rest of 47 patients with 2 or more segments 19 (40 %) developed asp.Out of the 100 patients, 32 were pain free with the outcome after 56 months after surgery, minimum of 24 and maximum of 95 months.Out of the rest, 48 patients reported an improvement of their symptoms 59 months after surgery minimum of 24 and maximum of 96 months after surgery, and the rest reported no significant improvement of the symptoms 65 months after surgery.25 patients had screw loosening determined by the presence of radiolucent lines at the screw/bone interface or cut out of the screws in normal or dynamic x-rays, as well as ct scans documented.10 in a one segment instrumentation out of which 8 required surgery because of symptomatic radiculopathy, surgeries were performed within 2 months and 6 years of the primary instrumentation.8 in 2 segment instrumentations out of which 4 showed no symptoms and required no renewed surgery up to the time of the study, but the rest did require surgery 1 to 3 years later.7 in 3 segment instrumentation, out of which 2 required renewed surgery.There was also recorded a screw breakage and a patient with a malposition and loosening which wasn¿t included in either category.This report is for an unknown depuy spine mono/polyaxial screws (viper sc screw).It captures the reported event of symptomatic screw loosening or breakage.This is report 4 of 4 for (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10869227
• MDR Text Key: 218522115
• Report Number: 1526439-2020-02250
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2020
• 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