MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; TAP, BONE

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown mono/ polyaxial screw/ unknown lot.Part and lot number 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.

Event Description

This report is being filed after the review of the following journal article: zotti mg et al.(2015), the outcome of pedicle screw instrumentation removal for ongoing low back pain following posterolateral lumbar fusion, journal of spine surgery, volume 1, number 1, pages 50-56, (australia).The primary aim of our study was to assess whether removal of pedicle screw instrumentation following elective lumbar fusion in our cohort was associated with satisfactory outcomes.Secondary outcomes of interest were to identify patient factors that may influence outcomes, the complication profile of the procedure and how our results compared to the existing literature.A total of 50 patients who had undergone lumbar fusion for discogenic back pain with subsequent pedicle screw instrumentation removal (unknown depuy spine expedium) in the preceding 3 years with a minimum of 18 months follow-up were reviewed.However, only 34 of these patients met inclusion criteria.There were 21 males and 13 females with a mean age of 49 years (range, 31-68 years).Surgery included re-use of previous midline posterior incision and the wiltse approach with removal of implants, confirmation of a solid fusion mass, washout and bone grafting of removal sites.During follow-up, routine assessment of patients was performed, initially to assess the state of the soft tissues and wound within the first 6 weeks and then a second assessment at 3 months to assess the short-term outcome from the procedure.The mean follow-up was 25 months (range, 18-36 months).Complications were reported as follows: excluded patients: 2 patients had radicular symptoms from malpositioned or broken screw.2 patients had positive infection at the operative site.Included patients: 1 patient had closed wound hematoma after the implant removal which resolved with aspiration and without the need for reoperation.This report is for the unknown depuy spine expedium.This report is for one (1) unknown mono/polyaxial screw.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Impacted product change updated the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 - CONSTRUCTS: EXPEDIUM
• Type of Device: TAP, BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12435215
• MDR Text Key: 270309680
• Report Number: 1526439-2021-01853
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention