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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 Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: unknown_medicrea(pedicular screw 3,5mmx22mm), serial/lot #: unknown, ubd: unknown , udi# unknown; product id: unknown_medicrea(pedicular screw 3,5mmx26mm). Which of the reported screw has lead the event to revision surgery. Hence, all the reported screws were referenced. Neither the device nor films of applicable imaging studies were 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 received from post market clinical study via manufacturer representative regarding an event happened during post-op of the reported product. The pre-op diagnosis was myelopathy and medical history includes diabetes. It was reported that, persistence of an unbroken screw head opposite the left c1 screw on the post operative control scan. Revision was performed to cut the screw head. The procedure or technique performed was implant of pass oct rod and screws. The levels implanted were not specified. No further complications reported.
 
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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 Key14185223
MDR Text Key290273452
Report Number1000432246-2022-00037
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 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
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 Received06/13/2022
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: 04/22/2022 Patient Sequence Number: 1
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