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

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

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.This report is for an unknown mono/polyaxial screws: expedium/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.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

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: nagata, k.Et al.(2020), skipping pedicle screw insertion into infected vertebra is a risk factor for revision surgery for pyogenic spondylitis in the lower thoracic and lumbar spine, international journal of spine surgery, vol.14, no.6, pp.989¿995 (japan).The purpose of this study was to compare the reoperation rate due to debridement or revision between the skipping pedicle screw insertion and the insertion of pedicle screws in all vertebrae in patients with pyogenic spondylitis.A single-institution retrospective cohort study was conducted in consecutive patients with pyogenic spondylitis in the lower thoracic and lumbar spine (t9¿s1) between january 2008 and december 2016.The patients were treated with interbody fusion plus posterior stabilization using pedicle screws and were divided into 2 groups as follows: (1) patients in whom 1 vertebra, usually the most erosive, was skipped in pedicle screw insertion (group skipping) and (2) pedicle screw insertion into all vertebrae (group all).Implants used were pedicle screws (expedium, depuy synthes, west chester, pa, or solera5.5/6.0, medtronic, minneapolis, mn).Mean follow-up length was 24 (11¿48) months.The following complications were reported as follows: group skipping.A 66-year-old male patient had a reoperation by pseudoarthrosis.A 75-year-old male patient had a reoperation by pseudoarthrosis.A 63-year-old female patient had a t4¿iliac fixation by pseudoarthrosis.A 76-year-old female patient had a reoperation by pseudoarthrosis.A 71-year-old female patient died 50 d after the first surgery.A 61-year-old male patient had a reoperation by pseudoarthrosis and by debridement.Group all 1 patient died in this group.1 patient had a reoperation by pseudoarthrosis.4 patients had a reoperation by debridement.This report is for unknown synthes expedium pedicle screws.This is report 6 of 6 for (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM
• 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 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14700033
• MDR Text Key: 294843426
• Report Number: 1526439-2022-00864
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/15/2022
• 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: 05/17/2022
• 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