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 Pain (1994); Non-union Bone Fracture (2369); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown cougar system/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.

Event Description

This report is being filed after the review of the following journal article: rentenberger, c.Et al.(2020), perioperative risk factors for early revisions in stand-alone lateral lumbar interbody fusion, world neurosurgery, vol.134, pages e657-e663 (usa).The objective of this study is to determine perioperative factors that increase the risk of early revisions after standalone lateral lumbar interbody fusion (sa-llif).From 2007 to 2016, a total of 133 patients underwent an sa-llif procedure.They were divided into 2 groups.Nonrevision group which had 108 patients (41 males and 67 females) with a mean age of 66.3 years and revision group which had 25 patients (10 males and 5 females) with a mean age of 68.6 years.Implants used were the cougar system (depuy synthes, raynham, massachusetts, usa).The following complications were reported as follows: 68% of patients had revision surgery for symptoms of pain.16% of patients had revision surgery for radiographic adjacent segment disease.16% of patients had revision surgery for pseudarthrosis.8% of patients had revision surgery for hardware failure.A total of 189 levels were categorized as mild subsidence (grade 0-i) and 69 levels as severe subsidence (grade ii-iii).This report is for an unknown synthes cougar system.This report captures the reported pain, radiographic adjacent segment disease and pseudarthrosis.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: 11851802
• MDR Text Key: 255954868
• Report Number: 1526439-2021-01004
• 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: Physician
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 04/21/2021
• 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