MAUDE Adverse Event Report: ORTHOFIX INC. FORZA SPACER; INTERVERTEBRAL FUSION DEVICE

Catalog Number 89-1707SP

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

During disc repair surgery, interbody cage of the orthofix forza spacer broke off in disc space at l5-s1.No idea how it could have been prevented.Sales rep from orthofix is going to file a defective product report with the company.Dr didn't want to go after the broken-off segment because of the high risk of further damage.He performed a scan of the patient the next day and it was determined the segment had not migrated.Therefore piece will be left in the patient.No patient harm occurred.

• Brand Name: FORZA SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 4852619
• MDR Text Key: 15307822
• Report Number: 4852619
• Device Sequence Number: 1
• Product Code: MAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 89-1707SP
• Device Lot Number: E03
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAY HAVE CONTRIBUTED TO THE FAILURE.; NOT SURE BUT THE DEVICE USED TO INSERT THE SPACER
• Patient Age: 51 YR