MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA LIGAPASS; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number	B08116040S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: country of event - germany.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.Pre-op diagnosis of patient was parkinson/osteoporosis.Medical history of patient includes, parkinson/osteoporose, t9 pvcr.It was reported that, the connector was broken.Revision surgery was performed due to the torn lamina ligaments.The ribbon was torn. there were no fragments of broken connector left inside patient body.Procedure/technique performed was cranial connection, sublaminar tunneled.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Product analysis of part # (b)(4).Lot # 23j0251 visual inspection confirmed the connectors were returned with both set screws threaded into the connector and a portion of the damaged tether looped in each as well.Optical inspection did not reveal any damage to the threads or outer structure of the implant.Functional inspection confirmed both connectors were able to attach and hold a sample rod.Each tether had a frayed end and a straight cut end.The tether appears to have been cut for removal.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LIGAPASS
• Common Device Name: BONE FIXATION CERCLAGE, SUBLAMINAR
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 19556256
• Report Number: 1000432246-2024-00012
• Device Sequence Number: 15131257
• Product Code: OWI
• UDI-Device Identifier: 03613720271253
• UDI-Public: 03613720271253
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: B08116040S
• Device Catalogue Number: B08116040S
• Device Lot Number: 23J0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 66 KG