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

Model Number	48230141
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; performed a surgery on a patient back in 2016 using a thoraco-lumbar-iliac screwing from a consignment and a loaner for the iliac part.On (b)(6) 2017, performed a revision surgery on this patient by implanting a cage in anterior and in posterior for a compression layout.Between these 2 dates, a stem of the iliac screwing detached from the stem-stem connector that made the link with lumbar screwing.The surgeon took the opportunity of the revision surgery to put back the iliac lumbar connection in place by changing the stem-stem connector as well as the stem.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: visual inspection of the device show that the device was returned in two pieces, with the blocker disengaged from the connector.No relevant manufacturing issues were identified.Conclusion: the plausible root cause of the event is determined to be a loose construct due to over tightening and rod not being seated in the device.
Event or Problem Description
It was reported that; performed a surgery on a patient back in 2016 using a thoraco-lumbar-iliac screwing from a consignment and a loaner for the iliac part.On (b)(6) 2017, performed a revision surgery on this patient by implanting a cage in anterior and in posterior for a compression layout.Between these 2 dates, a stem of the iliac screwing detached from the stem-stem connector that made the link with lumbar screwing.The surgeon took the opportunity of the revision surgery to put back the iliac lumbar connection in place by changing the stem-stem connector as well as the stem.

• 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: 6548507
• Report Number: 3005525032-2017-00055
• Device Sequence Number: 10895966
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 48230141
• Device Catalogue Number: 48230141
• Device Lot Number: B45768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 08/23/2017
• 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