MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 4823717580

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Event Description

It was reported that; tulip head broke off screw while inserting blocker.Update: all of the broken fragments were retrieved from the surgical site.There were no adverse consequences to the patient.

Manufacturer Narrative

Unanticipated hazard.Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The reported event occurred while doctor was using a standard blocker inserter.No persuader was being used by the surgeon according to communication with the sales representative.Surgical technique states the blocker is assembled onto the universal tightener for insertion.Conclusion: a definitive root cause of the event could not be determined with the given information.

Event Description

It was reported that; tulip head broke off screw while inserting blocker.Update: all of the broken fragments were retrieved from the surgical site.There were no adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 80MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5648310
• MDR Text Key: 46017973
• Report Number: 3005525032-2016-00052
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613252045793
• UDI-Public: (01)07613252045793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

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
• Device Operator: No Information
• Device Catalogue Number: 4823717580
• Device Lot Number: B33429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1