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

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown 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: yamasaki r., et al (2013) surgical outcomes of posterior thoracic interbody fusion for thoracic disc herniations, eur spine j volume 22, pages 2496¿2503 (japan).This retrospective study aims to investigate the surgical outcomes of posterior thoracic interbody fusion (ptif) with bilateral total facetectomies and pedicle screw fixation for myelopathy due to tdh.Between 1999 and 2010, twelve consecutive patients underwent ptif for myelopathy due to tdh.This study group consisted of 11 patients (7 men, 4 women) who were followed for at least 1 year.The mean age at surgery was 55.2 years (range 21¿81 years) and the average follow-up period was 4.3 years (range 1¿11 years).Pedicle screw fixation involved use of the steffee variable spine plating system (depuy spine, raynham, ma, usa) in the earlier five patients, and the expedium spine system (depuy spine, raynham, ma, usa) in the later six patients.The following complications were reported: a case of a (b)(6) year-old female (case no.3) had leakage of csf.Resolved with conservative treatment.A case of a (b)(6) year-old male (case no.10) had resulting pseudoarthrosis, which required revision surgery due to kyphosis deterioration.Loosening of the pedicle screws in the caudal vertebra and vacuum around the graft were detected.The findings of diffuse idiopathic skeletal hyperostosis (dish) were observed at the cranial levels of the ptif at postoperative 3 months.Improvement of at least one modified frankel grade was observed in all but one patient.Unchanged result in one patient.This report is for an unknown depuy spine steffee variable spine plating system and the expedium spine system.This report is for (1) unknown plates.This report is 1 of 4 for (b)(4).

• 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: 12436055
• MDR Text Key: 270500540
• Report Number: 1526439-2021-01863
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/07/2021
• 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