MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; PEDICLE SCREW, 5MM X 40MM

Model Number DIAMETER 5MM X 40MM

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Screw breakage detected between 3 month and 12 month post-op.Patient did not follow the postoperative recommendations.(b)(4).

Event Description

Screw breakage detected between 3 month and 12 month post-op.Patient did not follow the postoperative recommendations.

• Brand Name: PASS LP
• Type of Device: PEDICLE SCREW, 5MM X 40MM
• 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: 6788754
• MDR Text Key: 82992069
• Report Number: 1000432246-2017-00019
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2017

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?: No
• Device Operator: Physician
• Device Model Number: DIAMETER 5MM X 40MM
• Device Catalogue Number: B02215540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR