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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: ren dw, et al.(2018), comparison of the dynesys dynamicinternal system and transforaminal lumbar interbody fusion for degenerative l5/s1 disc herniation, orthopaedics, vol.9, no.6, pages 445-450, (china) the objective of the study is to compare the clinical outcomes of dynamic internal system (dynesys) and transforaminal lumbar interbody fusion for degenerative l5/s1 disc herniation.From january 2011 to january 2015, 82 patients with degenerative l5/s1 disc herniation were included in the study.38 patients (27 males, 11 females, mean age 49.5±11.6 years) were treated with dynesys dynamic internal fixation (dynesys group), and 44 patients (31 males, 13 females, mean age 49.5±11.6) were given transforaminal lumbar interbody fusion (tlif group).In the tlif group, patients were implanted with (4) unknown depuy spine pedicle screws placed in the pedicles of l5 and s1.An unknown manufacturer titanium rod and fusion cage were also implanted.In the dynesys group, patients were implanted with a competitor¿s pedicle screws.Clinical and imaging results were compared in 1, 3, 6, 12 and 24 months after surgery.Complications were reported as follows: (tlif group only) 11 patients had l4/5 adjacent segment degeneration.This report is for the unknown depuy spine pedicle screws.This is report 1 of 1 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.510k: this report is for an unknown device/unknown lot.Part and lot numbers 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.

• 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: 15378751
• MDR Text Key: 299457772
• Report Number: 1526439-2022-01551
• 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: 09/08/2022
• 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
• 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