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); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown mono/polyaxial screws/ 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 as no product was received.The investigation could not be completed, 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: yoo, c.Ryu, s.I., and park, j.(2009), fracture-related thoracic kyphotic deformity correction by single-stage posterolateral vertebrectomy with circumferential reconstruction and stabilization outcomes in 30 cases, journal of spinal disorders & techniques, vol 22, pages 492-501 (south korea).This study assesses single-stage thoracic vertebrectomy with circumferential reconstruction and stabilization.Preoperative and postoperative thoracic kyphotic angles and other outcomes are analyzed.Between 2004 and 2006, 30 patients underwent 31 single-stage thoracic vertebrectomies with circumferential reconstructions for thoracic spine fractures.There were 21 men and 9 women with a mean age of 54 years (range: 19 to 75 y).Implants used were thoracic pedicle screws (expedium, depuy j & j, raynham, ma).The mean follow-up was 17.21 months (range: 9 to 30 mo.).The following complications were reported: 1 patient had intraoperative dural laceration and a lumbar drain was placed for 5 days.2 patients developed superficial wound infections, which were both managed with revision closure and no hardware removal.2 patients had hardware failure, and each had a revision.1 patient had a follow-up computerized tomography, which showed a possible lucency around the graft site, that is, possible fusion failure.1 patient developed a second spinal bone metastasis, and the new lesion was removed by another single-stage simultaneous anterior and posterior vertebrectomy and reconstruction.This report is for an unknown depuy spine thoracic pedicle screws (expedium, depuy j & j, raynham, ma).This report is for (1) unknown mono/ polyaxial screws.This report is 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.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: EXPEDIUM
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12436217
• MDR Text Key: 270482427
• Report Number: 1526439-2021-01869
• Device Sequence Number: 1
• Product Code: MNH
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention