MAUDE Adverse Event Report: ORTHOFIX INC CONSTRUX MINI PEEK VBR SYSTEM; PARALLEL LATERAL SPACER 10MM

Model Number 45-3210

Device Problem Crack (1135)

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

Event Date 08/11/2016

Event Type  malfunction  

Event Description

The information provided states that during the initial surgery, at the time of impaction, two of the cages cracked.Since the surgery, the patient has made good progress.No further information is available at this time.

• Brand Name: CONSTRUX MINI PEEK VBR SYSTEM
• Type of Device: PARALLEL LATERAL SPACER 10MM
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 6133865
• MDR Text Key: 61442665
• Report Number: 2183449-2016-00023
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051246
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 45-3210
• Device Lot Number: D700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2010
• 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): Other