MAUDE Adverse Event Report: ORTHOFIX INC FIREBIRD SPINAL FIXATION SYSTEM; SET SCREW

Model Number	44-2001
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product returned for evaluation included all (10) set screws from the construct.It is unknown which of the (10) set screws were found to have come unseated from the pedicle screws.(b)(4).
Event or Problem Description
Information provided states that doctor performed pl fusion from t10-l2 on (b)(6) 2015.During follow up visit it was noticed that three set screws, (2) at l2 and (1) at l3, had backed out of the construct allowing the rods out of the tulips.Revision surgery was performed on (b)(6) 2016 to remove and replace 10 set screws.
Additional Manufacturer Narrative
Product returned for evaluation included all (10) set screws from the construct.It is unknown which of the (10) set screws were found to have come unseated from the pedicle screws.44-2001 lot o008 (2), s142 (1), s143 (2), s145 (5).
Event or Problem Description
Information provided states that doctor performed pl fusion from t10-l2 on (b)(6) 2015.During follow up visit it was noticed that three set screws, (2) at l2 and (1) at l3, had backed out of the construct allowing the rods out of the tulips.Revision surgery was performed on (b)(6) 2016 to remove and replace 10 set screws.

• Brand Name: FIREBIRD SPINAL FIXATION SYSTEM
• Common Device Name: SET SCREW
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5486788
• Report Number: 3008524126-2016-00006
• Device Sequence Number: 963697
• Product Code: NKB
• UDI-Device Identifier: 18257200009695
• UDI-Public: 18257200009695
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 44-2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR