• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDICREA INTERNATIONAL SA UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number UNKNOWN_MEDICREA
Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Country: (b)(6).The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a t4-iliac, t4-l5, sacrum and il iac thoraco-lumbar arthrodesis for an indication of neurological spine deformity.The patient had medical history of stent, scoliosis on 2013, smoking, sleep apnea syndrome, tracheotomy and hepatitis c.It was reported that the rod was protruding and screw mobility was observed and additional surgery was performed for removal of mate rial. there were no patient symptoms reported.There were no further complications reported regarding the event.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received regarding the event.It was reported that the screw has migrated and the rods were protruding.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13974442
MDR Text Key288377756
Report Number1000432246-2022-00026
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN_MEDICREA
Device Catalogue NumberUNKNOWN_MEDICREA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
Patient Weight54 KG
-
-