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

Model Number	189706114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 3 of 6 for (b)(4).

• Brand Name: UNIPLATE LRG DIA, 14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11558293
• Report Number: 1526439-2021-00522
• Device Sequence Number: 4075947
• Product Code: KWQ
• UDI-Device Identifier: 10705034180694
• UDI-Public: (01)10705034180694
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 189706114
• Device Catalogue Number: 189706114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 64