MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws (unk construct 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.Reporter is a j&j employee.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 a clinical evaluation report (cer) from a database related research activity (drra) for a total of 438 patients (mean age of 48 years) who were operated with the combination of expedium posterior instrumentation and concorde interbody cage between january 02, 2006, and november 22, 2020.The following complications have been identified as per the swedish spine registry (swespine) report: general complications - intraoperative complications: 1 patient death.6 dural tear.5 misplaced implants.1 root injury.4 other complications.Post-op complications within index hospitalization: 11 deep surgical site infections.28 superficial surgical site infections.6 patients had reintervention during stay: 1 had redecompression, 1 had repair of dural tear, 1 had replacement of implant, 1 had stop of bleeding.Readmission 1: a total of 27 patients: 4 had adjustment of implant.3 had drain of infection.3 had redecompression.7 had refusion.5 had removal of implant.5 others.Readmission 2: a total of 5 patients: 1 had adjustment of implant.1 had drain of deep infection.1 had drain of hematoma.1 had redecompression.1 had implant removal.Readmission 3: 1 had drain of infection.Readmission 4: 1 had drain of infection.Readmission: 1 had drain of infection.This is for depuy spine unk mono/polyaxial screws (unk construct expedium).It captures the reported events of implant adjustment, drain deep infection, hematoma, re-decompression and implant removal.This is report 2 of 8 for (b)(4).

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 531 patients (mean age of 48 years, 55 percent are females) who were operated with the combination of expedium posterior instrumentation and concorde interbody cage between january 02, 2006 and september 30, 2022.The following complications have been identified as per the swedish spine registry (swespine) report: postoperative complications within 1 year postoperatively: 39 patients had infection.Reoperations 1 7 patients had implant adjustment.3 patients had drain of infection.4 patients had redecompression.8 patients had refusion.5 patients had removal of implant.1 patient had repair of dural injury.1 patient had drain of hematoma.1 patient had unknown reoperation.Reoperation 2 2 patients had implant adjustment.1 patient had drain of hematoma.1 patient had drain of infection.1 patient had redecompression.1 patient had removal of implant 2 patients had refusion.Reoperation 3 2 patients had drain of infection.1 patient had removal of implant.1 patient had redecompression.Reoperation 4 1 patient had drain of infection.1 patient had removal of implant.Reoperation 5 1 patient had drain of infection.

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.H10 additional narrative: b5: event description updated after receipt of new information.D3: manufacturer email updated.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.D1: brand name updated.

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 12417772
• MDR Text Key: 270819619
• Report Number: 1526439-2021-01816
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2023
• 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