MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482378570
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; (b)(64) was the primary procedure.Product was implanted to treat for l4-iliac.Broken rod 6.0mm was discovered at l5-s1.On (b)(4), revision surgery was performed.During revision surgery closed screw 8.5x70 was found broken.It was replaced at l4-il.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the sales representative.The device was not returned.Manufacturing history was reviewed and no issues were identified.Due to the device not being returned, a definite root cause cannot be determined.
Event or Problem Description
It was reported that; (b)(6) 2013 was the primary procedure.Product was implanted to treat for l4-illac.Broken rod 6.0mm was discovered at l5-s1.On (b)(6) 2017, revision surgery was performed.During revision surgery closed screw 8.5x70 was found broken.It was replaced at l4-il.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 8.5 X 70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6992762
• Report Number: 3005525032-2017-00100
• Device Sequence Number: 13777903
• Product Code: MNH
• UDI-Device Identifier: 07613327002850
• UDI-Public: (01)07613327002850
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: No Information
• Device Model Number: 482378570
• Device Catalogue Number: 482378570
• Device Lot Number: B22635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1