MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; TI UNID MIS RODS Ø5.5MM

Catalog Number B33225512-17

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

The initial surgery was performed on (b)(6) 2019.At the 13 month follow-up the patient's x-ray showed the right rod broken in the lower lumbar spine.Currently there is not any information as to whether the patient will be revised.

Event Description

The initial surgery was performed on (b)(6) 2018.At the 13 month follow-up the patient's x-ray showed the right rod broken in the lower lumbar spine.Currently there is not any information as to whether the patient will be revised.Submission of a medical device report and the fda's release of that information is not an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.

• Brand Name: PASS LP
• Type of Device: TI UNID MIS RODS Ø5.5MM
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL; 5389 route de strasbourg; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg; rillieux-la-pape, 69140 ; FR 69140
• MDR Report Key: 9162663
• MDR Text Key: 209365500
• Report Number: 1000432246-2019-00013
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33225512-17
• Device Lot Number: 18F0698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 47 YR