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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 Break (1069)
Patient Problems Unspecified Infection (1930); Pain (1994); Device Embedded In Tissue or Plaque (3165)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative

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 patient having hardware removal procedure for right word coronal imbalance, anterior sagittal imbalance, severe thoracolumbar disc desiccation and collapse. Medical history: the patient had prior history of multiple spine surgeries ultimately resulting in t5-ilium posterior spinal fusion. After a recent fall, she presented with worsening thoracic back pain. Images showed a fracture of the left t5 screw and the left iliac bolt. Her failure to fully fuse prompted concern for indolent infection. The patient had a previous unid rod failure (implanted (b)(6) 2019 and revised (b)(6) 2020). The procedure involved was t5-iliac posterior spinal fusion, l5/s1 spo, l5/s1 plif. It was reported that the t5 and iliac screw broke post-operatively and partially removed, the screw shanks were left in the patient as they were not able to be removed. On (b)(6) 2021, the patient reported that she has a protrusion under her skin on her back and feels like the further the day goes on the more pain she gets in her back.  the patient had a pseudo arthrosis with broken screw at t5 and iliac where she was treated with removal of hardware and irrigation and debridement with provisional fixation t10-pelvis with bedrock fixation on (b)(6) 2021 the physician stated that from the ct scan of patient's t and l-spine, it is clear that the patient has significant nonunion throughout the whole spine which is the cause for her instrumentation failure. At this point this brings up the concern for an indolent infection. The hardware has failed as a result of non-union/infection. The initial surgery t5-iliac was performed on (b)(6) 2019, the patient then had a fall and broke the rods and had a revision surgery of l3-iliac on (b)(6) 2020 where the iliac screw then broke and were replaced on (b)(6) 2020.  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
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key12341563
MDR Text Key267237354
Report Number1000432246-2021-00007
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
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: 08/19/2021 Patient Sequence Number: 1
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