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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 Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2015
Event Type  Injury  
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l5-s1, t9-t10, t12-l1, t8-s1, t8-t12 and sacrum thoraco-lumbar arthrodesis for an indication of neurological spine deformity.It was reported that there was malposition of left l4 screw and the additional surgery was performed on (b)(6) 2015 for removal of l4 screw and analgesics treatment.The screw was wrongly placed and failure of pedicle aiming by the operator.There were no patient symptoms reported.There were no further complications reported regarding the event.
 
Manufacturer Narrative
Report source: (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.
 
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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 Key13796452
MDR Text Key287427575
Report Number1000432246-2022-00015
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
Report Date 03/17/2022
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
Device Operator Health Professional
Device Model NumberUNKNOWN_MEDICREA
Device Catalogue NumberUNKNOWN_MEDICREA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/18/2022
Initial Date FDA Received03/17/2022
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
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