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

Catalog Number 48230141

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/11/2016

Event Type  Injury  

Event Description

It was reported that the surgeon at the clinic, reported that he had to proceed to a revision surgery one month after the initial implantation because the external rod slipped from the junction connector and parted from it.Both sides of the assembly were concerned.

Manufacturer Narrative

Method: risk assesment.Result: the reported event was confirmed via the correspondence with the international representative.However, the device was discarded and is unavailable for evaluation.No lot # was provided, so a manufacturing record review could not be performed.No device was received back, so testing and inspection could not be performed to aid in determination of the cause of the event.Conclusion: over or under tightening of the setscrews for this device can lead to loosening of the construct and possible disengagement of a rod attached to this device.However, because the device is unavailable for evaluation, this cannot be determined conclusively.

Event Description

It was reported that the surgeon at the clinic, reported that he had to proceed to a revision surgery one month after the initial implantation because the external rod slipped from the junction connector and parted from it.Both sides of the assembly were concerned.

• Brand Name: XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM
• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5551954
• MDR Text Key: 42003152
• Report Number: 3005525032-2016-00034
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540602312
• UDI-Public: (01)04546540602312
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083393
• 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: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48230141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• 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
• Patient Outcome(s): Required Intervention