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U.S. Department of Health and Human Services

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

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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.
 
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Brand NameUNKNOWN
Type of DeviceTHORACOLUMBOSACRAL 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
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
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
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2022 Patient Sequence Number: 1
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