MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA ROD TO ROD CLAMP - AXIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	03805002
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Complaint, Ill-Defined (2331); Injury (2348)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient presented with end to end axial connector issue patient is coming back for a revision surgery.Details pending.Update (b)(6) 2017: patient was doing well post-op until he bent over and simply heard a "pop" noise.Thus resulting in pain and physicians visit.
Additional Manufacturer Narrative
The reported event was confirmed based on x- ray images provided.Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The definitive root cause of the event cannot be determined as the device was not returned for evaluation.
Event or Problem Description
It was reported that; patient presented with end to end axial connector issue patient is coming back for a revision surgery.Details pending.Update 9/19/2017: patient was doing well post-op until he bent over and simply heard a "pop" noise.Thus resulting in pain and physicians visit.

• Brand Name: XIA ROD TO ROD CLAMP - AXIAL
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6930792
• Report Number: 3005525032-2017-00095
• Device Sequence Number: 1443828
• Product Code: KWP
• UDI-Device Identifier: 04546540147998
• UDI-Public: (01)04546540147998
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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 Model Number: 03805002
• Device Catalogue Number: 03805002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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
• Patient Age: 70 YR
• Patient Weight: 95