MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number UNKNOWN_MEDICREA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/10/2020

Event Type  Injury  

Event Description

Information was received from post market clinical study, healthcare provider via manufacturer representative regarding an event happened during post-op of the reported products.The pre-op diagnosis was mentioned as neurological spine deformity and medical history includes high blood pressure, herniated disc l3l4l5, gonarthrosis, pancytopenia being explored, herniated c6 operated, heterozygous sickle cell disease, (b)(6) cured (b)(6) 2016.It was reported that, the patient had a symptom of pseudarthrosis at l5s1.The s1 screw has mobility.Revision surgery was performed to explant the reported s1 screw and it was discarded.The date of explant was unknown.There were no further complications reported regarding the event.

Manufacturer Narrative

Report source: (b)(6).Patient symptom - pseudarthrosis at l5s1 level.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13786027
• MDR Text Key: 289488338
• Report Number: 1000432246-2022-00013
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN_MEDICREA
• Device Catalogue Number: UNKNOWN_MEDICREA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male