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

Model Number UNKNOWN_MEDICREA

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

Report source: country: (b)(6).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 was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having unid rod implantation for an indication of adolscent idiopathic scoliosis.It was reported that the twin rods at the proximal part of the instrumentation was palpable under the skin and caused pain when mobilizing the shoulders.The additional surgery was performed on (b)(6) 2021 and removal of the hooks at t2-t3 and cutting of rods and costoplasty was performed.There were no further complications reported regarding the event.

• Brand Name: UNKNOWN
• Type of Device: 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: 14139639
• MDR Text Key: 289515537
• Report Number: 1000432246-2022-00034
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN_MEDICREA
• Device Catalogue Number: UNKNOWN_MEDICREA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male