MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482317590
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Injury (2348)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient presented in post op clinic with pain/discomfort.The patient had bilateral non-union across the sacroiliac joint which was confirmed during x-ray.It was reported that the screw had broken at the proximal end of the shaft just above the head.The patient underwent surgery to remove the head and proximal end leaving behind shaft of the screw.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via visual inspection.The screw shank was fractured as reported.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Material analysis of the returned screw found that the screw fractured in fatigue due to reverse bending.The elemental constituents were as specified on the print.No material or manufacturing defects were found.The device ifu states "delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/ nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture." conclusion: the root cause is determined to be fatigue fracture due to non -union.The lack of fusion over 2-3 years subjected the screw to excessive and repeated stresses which caused a fatigue fracture in reverse bending.
Event or Problem Description
It was reported that a female patient presented in post op clinic with pain/discomfort.The patient had bilateral non-union across the sacroiliac joint which was confirmed during x-ray.It was reported that the screw had broken at the proximal end of the shaft just above the head.The patient underwent surgery to remove the head and proximal end leaving behind shaft of the screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 90 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7970662
• Report Number: 0009617544-2018-00239
• Device Sequence Number: 13503259
• Product Code: NKB
• UDI-Device Identifier: 04546540562418
• UDI-Public: 04546540562418
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482317590
• Device Lot Number: B17106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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: Required Intervention
• Patient Age: 38 YR