MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 R T R CONNECTOR PARALLEL SMALL 4.5 - 4.5; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48135005
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; initial procedure did for scoliosis on (b)(6) 2012.Additional procedure did on (b)(6) 2017.Difficult to be loosed a connector of the lod by the blocker.So opened(expanded) all of cranial side additionally and removed some screws, then removed rod and blocker together.
Additional Manufacturer Narrative
Visual inspection, functional inspection, device history review, complaint history review, risk assessment.It was confirmed the blocker was jammed into the connector and could not be removed.No relevant manufacturing issues were identified as all units met stryker specifications.The root cause cannot be conclusively determined as this event is multi-factorial in nature.
Event or Problem Description
It was reported that; initial procedure did for scoliosis on (b)(6) 2012.Additional procedure did on (b)(6) 2017.Difficult to be loosed a connector of the lod by the blocker.So opened(expanded) all of cranial side additionally and removed some screws, then removed rod and blocker together.

• Brand Name: XIA TITANIUM 4.5 R T R CONNECTOR PARALLEL SMALL 4.5 - 4.5
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6370591
• Report Number: 0009617544-2017-00067
• Device Sequence Number: 1081600
• Product Code: MNI
• UDI-Device Identifier: 04546540649331
• UDI-Public: (01)04546540649331
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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 Catalogue Number: 48135005
• Device Lot Number: 142986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/03/2017
• 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: Other
• Patient Weight: 55