MAUDE Adverse Event Report: ORTHOFIX INC PROVIEW MINIMAL ACCESS PORTAL SYSTEM; FLEXIBLE ARM PROVIEW RETRACTOR SYSTEM

Model Number 70-5002

Device Problems Failure to Align (2522); Naturally Worn (2988)

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

Event Date 10/30/2017

Event Type  malfunction  

Event Description

Based on the information provided, the 70-5002 flexible arm seemed worn and would not hold in place tightly.A different product was used to complete the surgery resulting in an increase in surgery time.There were no adverse effects to the patient.

• Brand Name: PROVIEW MINIMAL ACCESS PORTAL SYSTEM
• Type of Device: FLEXIBLE ARM PROVIEW RETRACTOR SYSTEM
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: chenoa perez ; 3451 plano parkway; lewisville, TX 75056 ; 2149372362
• MDR Report Key: 7046551
• MDR Text Key: 93449496
• Report Number: 2183449-2017-00026
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 70-5002
• Device Lot Number: 13788-KA07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1