MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; UNID ROD

Catalog Number B33225512-08

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

The unid rods were correctly identified with the right patient codes.Even if the patient a received the rods planned for patient b, the post-op profile obtained matched with the pre-op profile planned.The patient b received competitor rods not pre-bent but the surgeon bent the rods accordingly to the patient specific parameters right before the implantation.The x-ray and patients' information available show that the profile obtained for both patients meet the initial requirement even though the rods were switched.There is no adverse effects for both patients.

Event Description

Following a mix-up of rods in the same hospital: patient a received pre-bent rods planned for patient b.Patient b received rods from a competitor bent by the surgeon right before implantation.

• Brand Name: PASS LP
• Type of Device: UNID ROD
• 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: 9360443
• MDR Text Key: 170112222
• Report Number: 1000432246-2019-00014
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33225512-08
• Device Lot Number: 0VJMQMXS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 0 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 67 YR