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

Model Number 48236043

Device Problems Mechanical Problem (1384); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6989372
• MDR Text Key: 91196479
• Report Number: 0009617544-2017-00385
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48236043
• Device Catalogue Number: 48236043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• 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