MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN PLATES; PLATE, FIXATION, BONE

Device Problem Migration (4003)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk -plates/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: jang h., et al ( 2020) does graft position affect subsidence after anterior cervical discectomy and fusion, global spine journal volume xxxx, pages 1-9 (korea, south).This retrospective cohort study aims to investigate if graft position affects allograft subsidence after acdf with allograft and plate.In addition, we aimed to determine if there is a difference in clinical results based on allograft subsidence and implant position.From january 2012 to october 2018, 92 patients (59 male and 33 female patients; mean age, 48.7 years) who underwent single-level acdf with allograft and plate were included in the study.All patients underwent single-level acdf with allograft and plate procedures.To accomplish interbody fusion, one surgeon (dkc) used freeze-dried bone allograft, a skyline plate (dupuy synthes), fixed screws at the top of the fusion level, and variable screws at the bottom.Another surgeon (khk) used a machined allograft, an atlantis plate (medtronic sofamor- danek), and fusion was performed using fixed screws.Patients were divided into 2 groups according to graft location.Of the 92 grafts,73 was anteriorly positioned (anterior group) with 44 males and 29 females age 48.2 + 10.3 years and 19 were center positioned (center group) with 15 males and 4 females age 48.1 + 10.4 years.The following complications were reported: -a case of implant subsidence in a 48-year-old man with c5/6 degenerative disc disease who underwent discectomy with allograft and plate.Comparison of immediate postoperative lateral study with a 1-year radiograph demonstrates a loss of 2.48mm of segmental vertebral body height (figure 2).10 subsidence.13 pseudarthrosis.This report is for an unknown synthes skyline plate.A copy of the literature article is being submitted with this medwatch.This report is for (1) unknown plates.This report is 1 of 6 for (b)(6).

• Brand Name: UNKNOWN PLATES
• Type of Device: PLATE, FIXATION, BONE
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12256583
• MDR Text Key: 264475725
• Report Number: 1526439-2021-01589
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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
• Date Manufacturer Received: 07/02/2021
• 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