MAUDE Adverse Event Report: ORTHOFIX INC PILLAR SA SPACER; PILLAR SA PARTIAL VBR

Model Number 49-3218

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/04/2015

Event Type  malfunction  

Event Description

Information provided states that during a l5-s1 case that the peek spacer broke during implantation.The implant was removed and replaced with another available implant.

Manufacturer Narrative

The broken device was received for failure analysis.The fit check was performed with one of the available implant insertion instruments.The broken device was able to fit properly with insertion device (49-1100).The surgeon was performing surgery using alif approach at l5-s1.The rasp/trial used in this case is 40x28x18 which is appropriate for this size.The implant inserter tool is typically impacted with mallet to place the interbody implant at the right location.It is not known whether the levering force was applied on the insertion tool while trying to place the implant into already prepared interbody space.It is also not known whether the levering force was applied on the insertion tool while removing it from the implant.As reported in the complaint the implant broke during implantation.The exact root cause cannot be determined with available information, but the mechanical overstress applied during implantation can not be ruled out in this case.

• Brand Name: PILLAR SA SPACER
• Type of Device: PILLAR SA PARTIAL VBR
• 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: 5256106
• MDR Text Key: 32486305
• Report Number: 3008524126-2015-00038
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 49-3218
• Device Lot Number: H344
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• 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 Outcome(s): Other
• Patient Age: 52 YR