MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48135103
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the extended connector was fractured in the patient's body.Revision surgery was completed to remove the fractured device, and a replacement was used.
Additional Manufacturer Narrative
Method: photo and x-ray review, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via photos and x rays provided by the rep.The device was not able to be located by the distributor and is unavailable for evaluation, however photos were provided showing the device fractured at the center shaft on one side, and then a second picture showing the device fractured into 2 pieces.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified the original surgery occurred in 2015, meaning the device was implanted for about 3 years.Review of the x rays showed that the construct was fixed at two upper thoracic levels and at 2 lumbar levels, with no additional fixation in between.The existing curve and the placement of the devices allowed for a large bending moment to exist within the non-fixed region, which can eventually cause a fatigue breakage of connector.The connector was not returned to verify this, however this is the most likely root cause.Patient post op activity level could have also contributed to the event.Capa was opened to house the investigation and resulting design change for this issue.New growth connector were introduced to reduce the occurrence of extended connector fracture.Conclusion: the potential root causes for the event includes fatigue breakage and patient post-op activity level.
Event or Problem Description
It was reported that the extended connector was fractured in the patient's body.Revision surgery was completed to remove the fractured device, and a replacement was used.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7870642
• Report Number: 0009617544-2018-00218
• Device Sequence Number: 186929
• Product Code: MNH
• UDI-Device Identifier: 04546540449580
• UDI-Public: 04546540449580
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: No Information
• Device Catalogue Number: 48135103
• Device Lot Number: 129542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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: 12 YR