MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR

Catalog Number UNK CAGE/SPACER

Device Problem Migration (4003)

Patient Problem Physical Asymmetry (4573)

Event Date 12/11/2010

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporters state: (b)(6).Investigation summary: 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

Yao n., wang c., wang w., wang l., (2011) full-endoscopic technique for anterior cervical discectomy and interbody fusion: 5-year follow-up results of 67 cases, eur spine j volume 20, pages 899¿904 (china).This study aims to report the feasibility of acdf using an endoscopic technique, 76 patients with cervical disorders were treated by this technique since 2000.Between january 2000 and january 2004, 76 patients with a mean age of 50.3 years (range 35¿67 years, 43 m/33 f), underwent endoscopic acdf for cervical disc herniation.A total of nine patients were lost to follow up.Thus, 67 patients were included in this study.A proper carbon fiber reinforced polymer (cfrp) cage (depuy, usa) was selected and filled with autogenic iliac crest bone graft prior to definitive placement.All patients were followed up of a minimum of 5 years (5¿8 years).The following complications were reported as follows: one patient required revision by means of open acdf because of adjacent segment disc herniation after 6 years post-operatively.3 patients reported poor results.At 6 months postoperatively, bony fusion was achieved in 61 patients only.With increasing time, aih slightly decreased when compared with that measured immediately after the operation.At the final follow-up, 42 patients were lordotic, 19 patients were neutral, and 6 patients (8.9%) had mean kyphotic alignment.Subsidence of crfp cage was observed in four patients.This report is for an unknown depuy spine cfrp cage.This impacted product captures the following adverse events: one patient required revision by means of open acdf because of adjacent segment disc herniation after 6 years post-operatively.3 patients reported poor results.At 6 months postoperatively, bony fusion was achieved in 61 patients only.With increasing time, aih slightly decreased when compared with that measured immediately after the operation.At the final follow-up, 42 patients were lordotic, 19 patients were neutral, and 6 patients (8.9%) had mean kyphotic alignment.This report is for one (1) unknown cage/spacer.This report is 1 of 2 for (b)(4).

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR
• 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 ; chemin-blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 11942627
• MDR Text Key: 254478137
• Report Number: 1526439-2021-01114
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CAGE/SPACER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1