MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number	482318545
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Numbness (2415); No Code Available (3191)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a surgery and complained of pain and numbness after the surgery.The surgeon noticed that the screw which was implanted in s1 was contacting to nerve.Therefore, revision surgery was performed on (b)(6) 2017.The insertion direction of the screw was changed, the screw size was changed with 8.5×45 and rod length was also changed with 6.0×40.
Additional Manufacturer Narrative
Method: risk assessment; result: no lot # was provided, so a manufacturing record review could not be performed.The device was not returned and is unavailable for evaluation as it was disposed off conclusion: the plausible root cause of the event maybe use-error.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a surgery and complained of pain and numbness after the surgery.The surgeon noticed that the screw which was implanted in s1 was contacting to nerve.Therefore, revision surgery was performed on (b)(6) 2017.The insertion direction of the screw was changed, the screw size was changed with 8.5×45 and rod length was also changed with 6.0×40.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6578647
• Report Number: 3005525032-2017-00059
• Device Sequence Number: 10989186
• Product Code: MNH
• UDI-Device Identifier: 04546540598592
• UDI-Public: (01)04546540598592
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 482318545
• Device Catalogue Number: 482318545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: 47 YR