MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48236043
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the or manager at the hospital reported that : " the device could not be implanted as a screw was missing".10/30/2017 update: responses received from the customer who replied that : " the procedure ended well even if the surgeon had to find a solution and implanted another implant which was less suited for the patient (another size was proposed and implanted) , no medical intervention, no surgical delay, adverse consequences for the patient as the implant is not the one planned at the beginning of the surgery.
Additional Manufacturer Narrative
Method: risk assessment; results: visual, dimensional, material and functional analysis could not be performed as the device was not returned and no lot# was provided.Conclusion: there is not enough information nor is the device available to determine a definite root cause.
Event or Problem Description
It was reported that; the or manager at the hospital reported that: " the device could not be implanted as a screw was missing".On 10/30/2017 update: responses received from the customer who replied that: " the procedure ended well even if the surgeon had to find a solution and implanted another implant which was less suited for the patient ( another size was proposed and implanted) no medical intervention, no surgical delay, adverse consequences for the patient as the implant is not the one planned at the beginning of the surgery.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6989372
• Report Number: 0009617544-2017-00385
• Device Sequence Number: 16451063
• Product Code: MNI
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48236043
• Device Catalogue Number: 48236043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/30/2017
• 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