MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48230000

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2016

Event Type  malfunction  

Event Description

It was reported that; the surgeon told the rep over the phone that he has had 2-3 different patients blocker pop off.(patient #2).Related to (b)(4).

Manufacturer Narrative

Method: risk assessment; results: no lot # was provided, so a manufacturing record review could not be performed.The device was not returned for inspection.Conclusion: therefore, a plausible root cause cannot be conclusively determined, as there is not enough information to determine a probable cause and the device was not returned for inspection.

Event Description

It was reported that; the surgeon told the rep over the phone that he has had 2-3 different patients blocker pop off.(patient #2).Related to pi (b)(4).

• Brand Name: XIA 3 TITANIUM BLOCKER
• 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: 5757012
• MDR Text Key: 49130458
• Report Number: 3005525032-2016-00068
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540560193
• UDI-Public: (01)04546540560193
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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