MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 BLOCKER; PEDICLE SCREW SPINAL SYSTEM

Model Number	48130000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon discovered on (b)(6) 2017 the rods were not connected to the s1 screws from a case we did on (b)(6) 2017 with the screw system.We are redoing the hardware to connect the rods on (b)(6) 2017.On original surgery (b)(6) 2017 the rods were torqued down in correct position at end of case.Procedure was completed as per the technique guide but would like the torque wrench to be evaluated to make sure it functioned properly.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.One blocker had a very light indentation only on one side of it, which is a sign the blocker may have been undertightened.Conclusion: the plausible root cause of the event is determined to be use-error.
Event or Problem Description
It was reported that; surgeon discovered on (b)(6) 2017 the rods were not connected to the s1 screws from a case we did on (b)(6) 2017 with the screw system.We are redoing the hardware to connect the rods on (b)(6) 2017.On original surgery (b)(6) 2017 the rods were torqued down in correct position at end of case.Procedure was completed as per the technique guide but would like the torque wrench to be evaluated to make sure it functioned properly.

• Brand Name: XIA TITANIUM 4.5 BLOCKER
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6671767
• Report Number: 0009617544-2017-00263
• Device Sequence Number: 2059466
• Product Code: MNI
• UDI-Device Identifier: 04546540448897
• UDI-Public: (01)04546540448897
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48130000
• Device Catalogue Number: 48130000
• Device Lot Number: MW7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/27/2017
• 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
• Patient Age: 71 YR
• Patient Weight: 58