MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Swelling (2091)

Event Date 04/17/2016

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/spacer/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.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: alimi m, njoku i, hofstetter c p, et al.(2016), anterior cervical discectomy and fusion (acdf): comparison between zero profile implants and anterior cervical plate and spacer, cureus, volume 8 (4), pages 1-15, doi 10.7759/cureus.573 (usa).The aim of this retrospective, prospective, cohort study is to compare zero-profile devices to conventional acdf with an anterior plate, focusing on the rate of persistent dysphagia and prevertebral soft-tissue swelling.Between october 2007 to october 2011, a total of 104 patients (53 male and 51 female) with a mean age of 55.9 ± 1.20 who underwent anterior cervical discectomy and fusion (acdf) were included in the study.Of these patients, 35 (18 males and 17 females with a mean age of 51.5+/-1.95 years) were implanted with depuy carbon-fiber cage (bengal, depuy synthes) combined with an anterior plate (skyline, depuy synthes).The mean clinical follow-up was was 14.8+/-2.13 months.Complications were reported as follows: 14 patients had an incidence of immediate postoperative dysphagia.7 patients had an incidence of dysphagia at the latest follow-up.Unknown patients had prevertebral soft tissue swelling at immediate postoperative with a mean of 20.48+/- 0.85 and at the latest follow-up with a mean of 13.72 +/- 0.67.This report is for the depuy carbon-fiber cage (bengal, depuy synthes).It captures the reported events of dysphagia and prevertebral soft tissue swelling.This is report 1 of 3 for (b)(4).

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 9558212
• MDR Text Key: 189364528
• Report Number: 1526439-2020-00201
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• 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
• Date Manufacturer Received: 12/11/2019
• 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