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

Device Problems Device Slipped (1584); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: wang h., wang j., and tian w.(2020), clinical effect of cbt screw fusion in patients with osteoporosis and spondylolisthesis, journal of guizhou medical university, vol.45 (9), pages 1088-1092 (china).The aim of this study is to investigate the clinical effect of cortical bone trajectory (cbt) screw fusion in the treatment of osteoporotic patients with lumbar spondylolisthesis.Between may 2017 to may 2019, a total of 82 patients were included in the study.These patients were divided into observation group (cbt screw fusion, n=40; 15 males and 25 females; average age of 62.03 ± 4.72 years [42 to 78 years]) and control group (traditional pedicle (ps) screw fusion, n=42; 18 males and 24 females; average age of 64.82 ± 5.02 years [44 to 80 years]).A cage from competitor and screws [diameter 5.5~6.0 mm, length 30 ~ 35 mm, johnson & johnson medical (shanghai) co., ltd.] were used.The patients were followed up for 10 to 34 months.The following complications were reported as follows: observation group: 2 patients were ineffective (clinical symptoms and bone mineral density did not improve or aggravate).38/40 patients had postoperative fusion.1 patient had pseudarthrosis.1 patient had cerebrospinal fluid leakage.1 patient had infection.Control group: 9 patients were ineffective (clinical symptoms and bone mineral density did not improve or aggravate).32/42 patients had postoperative fusion.3 patients had screw loosening or falling off.2 patients had pseudarthrosis.2 patients had cerebrospinal fluid leakage.3 patients had infection.This report is for an unknown depuy spine mono/polyaxial screws.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unknown mono/polyaxial screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Additional device product codes: mni, kwp, kwq, nkb, osh.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.

• Brand Name: UNK MONO/POLYAXIAL SCREWS
• 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: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15373459
• MDR Text Key: 299445338
• Report Number: 1526439-2022-01548
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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: 08/15/2022
• 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