MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS OCT; POSTERIOR SPINAL SYSTEM

Model Number Ø3.5 MM X12 MM

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 05/02/2014

Event Type  Injury  

Manufacturer Narrative

Checking the compliance of the returned polyaxial screw with requirements is not practical.Device history record was reviewed.No documentation was found that would indicate a non-conformance to specifications.The results of tests performed on the device during its manufacturing indicate compliance with the requirements.

Event Description

The event happened during posterior cervical stabilization surgery.When performing the final nut tightening, the entire screw post pulled out.The surgeon was not using the counter torque extension breaker.

• Brand Name: PASS OCT
• Type of Device: POSTERIOR SPINAL SYSTEM
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 14 porte du grand lyon; neyron, 01700 ; FR 01700
• Manufacturer (Section G): MEDICREA TECHNOLOGIES; chef de baie; larochelle, 17000 ; FR 17000
• Manufacturer Contact: isabelle broca ; 14 porte du grand lyon; neyron, 01700 ; FR 01700 ; 47 2018787
• MDR Report Key: 5167286
• MDR Text Key: 28907034
• Report Number: 1000432246-2015-00004
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Ø3.5 MM X12 MM
• Device Catalogue Number: B17213512
• Device Lot Number: 14B0489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 77