MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM R T R PARALLEL CONNECTOR ANGLED - SIDE LOADING; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	48235010
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgeon inserted the screws to l2-3(fixation extended).The surgeon used the angled open connector.When the surgeon tightened the blocker of connector, the blocker was not tightened.Therefore the surgeon changed the angled open connector to brand new connector.
Additional Manufacturer Narrative
Method:device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: no further investigation for this event is possible at this time as no devices and insufficient information was received.
Event or Problem Description
It was reported that during the surgery, the surgeon inserted the screws to l2-3(fixation extended).The surgeon used the angled open connector.When the surgeon tightened the blocker of connector, the blocker was not tightened.Therefore the surgeon changed the angled open connector to brand new connector.

• Brand Name: XIA 3 TITANIUM R T R PARALLEL CONNECTOR ANGLED - SIDE LOADING
• 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: 6015260
• Report Number: 3005525032-2016-00126
• Device Sequence Number: 270816
• Product Code: MNH
• UDI-Device Identifier: 04546540602404
• UDI-Public: (01)04546540602404
• Combination Product (Y/N): N
• 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): 02/21/2017

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 Catalogue Number: 48235010
• Device Lot Number: B60512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1