MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA UNID; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	B33126012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other: infection and hemorrhage.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from post market clinical study, healthcare provider via manufacturer representative regarding an event happened during post-op of the reported products.The pre-op diagnosis was degenerative kyphoscoliosis and medical history includes two herniated discs.It was reported that, disassembly of the material on (b)(6) 2017 and 7 days after bleeding occurred from scar due to infection.Revision surgery was performed on (b)(6) 2017 and the rod was changed.It was unknown, if any additional treatment was performed for infection.The reported rod was discarded.No further complications reported.

• Brand Name: UNID
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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 Key: 13658222
• Report Number: 1000432246-2022-00009
• Device Sequence Number: 13939013
• Product Code: MNI
• UDI-Device Identifier: 03613720205760
• UDI-Public: 03613720205760
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: B33126012
• Device Catalogue Number: B33126012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG