MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48233540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a procedure on (b)(6) 2016 for adolescent scoliosis correction.Surgery went well, correction obtained with no complication.Screws placed t3-l3.Patient was brought back for surgery (b)(6) 2018 due to l3 left sided screw backed out and potential cause of pain.Surgeon decided to remove all instrumentation as the spine has fused and instrumentation no longer needed.On removing the screws, one of the screws was found broken.This caused no issue to the patient and wasn't the reason for the revision surgery.The patient had a total of 21 screws in originally.One screw had backed out and one screw was broken.
Additional Manufacturer Narrative
The event was confirmed based on the communication with the sales representative.X rays were provided for evaluation.The screw was lost at the hospital during sterilization and is unavailable for evaluation.Manufacturing history was reviewed and no issues were identified.The patient was revised approximately 2 years after the initial surgery due to left screw backing out potentially causing pain.The patient had good bone quality, no co-morbidities, nonsmoker, adolescent idiopathic scoliosis condition, normal post op activity level and did not suffer a fall.It was reported that the patient fused and the instrumentation was no longer needed.It is stated in the ifu that "these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed." the device was implanted for a period of almost 2 years.The most likely root cause is device was used past its functional purpose, with excessive force placed by the surgeon and non tapping possibly contributing to the event.
Event or Problem Description
It was reported that a patient had a procedure on (b)(6) 2016 for adolescent scoliosis correction.Surgery went well, correction obtained with no complication.Screws placed t3-l3.Patient was brought back for surgery (b)(6) 2018 due to l3 left sided screw backed out and potential cause of pain.Surgeon decided to remove all instrumentation as the spine has fused and instrumentation no longer needed.On removing the screws, one of the screws was found broken.This caused no issue to the patient and wasn't the reason for the revision surgery.The patient had a total of 21 screws in originally.One screw had backed out and one screw was broken.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7483031
• Report Number: 0009617544-2018-00100
• Device Sequence Number: 144336
• Product Code: OSH
• UDI-Device Identifier: 07613327001037
• UDI-Public: (01)07613327001037
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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 Model Number: 48233540
• Device Catalogue Number: 48233540
• Device Lot Number: 14H339
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1