MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	48230141
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon faced an issue when screwing the connector screws.Once the tightening was completed, he noticed that the connector was still moving on the rod.He tried to tighten more but the connector was still moving on the rod.He changed the small screws but the connector was still moving on the rods.He changed the connector.
Additional Manufacturer Narrative
Lot#: b26647.Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was found to have its threading deformed.No relevant manufacturing issues were found upon manufacturing history review.Conclusion: it is likely that the surgeon applied too much torque on the set screws, cause them to strip during the procedure.However, no information could not be obtained despite multiple follow up attempts, so at this time the root cause could not be determined conclusively.
Event or Problem Description
It was reported that the surgeon faced an issue when screwing the connector screws.Once the tightening was completed, he noticed that the connector was still moving on the rod.He tried to tighten more but the connector was still moving on the rod.He changed the small screws but the connector was still moving on the rods.He changed the connector.

• Brand Name: XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM
• 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: 5551958
• Report Number: 3005525032-2016-00035
• Device Sequence Number: 974183
• Product Code: MNH
• UDI-Device Identifier: 04546540602312
• UDI-Public: (01)04546540602312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2016

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 Catalogue Number: 48230141
• Device Lot Number: B26647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1