MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Fatigue (1849); Failure of Implant (1924); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Seroma (2069); Stenosis (2263); Non-union Bone Fracture (2369); Osteolysis (2377); Numbness (2415); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra): a retrospective review of clinical outcomes following posterior lumbar interbody fusion with conduit¿ plif cages.The cases took place between 2019 and 2021.Adverse outcomes were as follows: 1 incidence of dural tear.9 incidences of back pain.5 incidences of pain, si joint.4 incidences of adjacent segment disease.3 incidences of seroma.2 incidences of wound dehiscence.1 incidence of weakness of lower extremities.1 incidence of nerve damage.1 incidence of foot drop.1 incidence of foraminal stenosis.1 incidence of infection.1 incidence of rod fracture.This report involves one unk - rods.This is report 2 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.Additional narrative: subject (b)(6) was identified to have experienced postoperative rod fracture on (b)(6) 2022.This subject was 68 years of age, and had a medical history of degenerative disc disease with radiculopathy, asthma, and obesity.It is unknown whether the other adverse events can also be attributed to this patient.This report is for an unknown rod/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.

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.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: UNKNOWN RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17004967
• MDR Text Key: 315964442
• Report Number: 1526439-2023-00910
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/30/2023
• 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