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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/11/2016
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• 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: 5551954
• Report Number: 3005525032-2016-00034
• Device Sequence Number: 11003687
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48230141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 07/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention