MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNIPLATE LRG DIA, 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 189706114

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the patients hardware become loose due to poor bone quality and non compliance.Patient is status post 3 level anterior cervical discectomy and fusion (acdf).Initial procedure was performed on (b)(6) 2021.Patient hardware was explanted on (b)(6) 2021.Patient and procedure outcome were unknown.No further information provided.This report is for one (1) uniplate lrg dia, 14mm.This is report 6 of 6 for (b)(4).

• Brand Name: UNIPLATE LRG DIA, 14MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 11558298
• MDR Text Key: 243561699
• Report Number: 1526439-2021-00523
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034180694
• UDI-Public: (01)10705034180694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171439
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 189706114
• Device Catalogue Number: 189706114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• 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
• Patient Weight: 64