MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317540
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the procedure was plif.Attempt to tighten the l5 left screw by torque wrench during final fasting.It couldn't connect the anti-torque-key on screw head due to pressed by outer muscle.Attempted to start a final fasten again for l4 left screw after connected the anti-torque-key with l4 left screw head.But there was cut out the l5 left screw under about 12n.Removed the blocker and the rod both.Inserted the l5 left screw to progress in a new direction, however there was found a movement of screw again.Then created another new screw hole and implanted other screw with no compression but it remained a slight motion on screw.Complete the procedure.No medical intervention and no adverse consequence reported at this time.
Additional Manufacturer Narrative
Additional request for information (11/24/2016) clarified the following; "the l5 was cut out during fasting the l4 by 12n.An additional screw hole was created at another level other than l5." investigation is currently in progress to understand the root cause of the reported event.A follow up report will be submitted upon investigation conclusion and/or additional information made available.
Event or Problem Description
It was reported that; the procedure was plif.Attempt to tighten the l5 left screw by torque wrench during final fasting.It couldn't connect the anti-torque-key on screw head due to pressed by outer muscle.Attempted to start a final fasten again for l4 left screw after connected the anti-torque-key with l4 left screw head.But there was cut out the l5 left screw under about 12n.Removed the blocker and the rod both.Inserted the l5 left screw to progress in a new direction, however there was found a movement of screw again.Then created another new screw hole and implanted other screw with no compression but it remained a slight motion on screw.Complete the procedure.No medical intervention and no adverse consequence reported at this time.Update: (24-nov-2016) per additional correspondence; the reported issue occurred with the l5 screw only.The l5 was cut out during fasting the l4 by 12n.An additional screw hole was created at another level other than l5.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the customer reported event is not using the anti-torque key during final tightening.
Event or Problem Description
It was reported that; the procedure was plif.Attempt to tighten the l5 left screw by torque wrench during final fasting.It couldn't connect the anti-torque-key on screw head due to pressed by outer muscle.Attempted to start a final fasten again for l4 left screw after connected the anti-torque-key with l4 left screw head.But there was cut out the l5 left screw under about 12n.Removed the blocker and the rod both.Inserted the l5 left screw to progress in a new direction, however there was found a movement of screw again.Then created another new screw hole and implanted other screw with no compression but it remained a slight motion on screw.Complete the procedure.No medical intervention and no adverse consequence reported at this time.Update: (24-nov-2016) per additional correspondence; the reported issue occurred with the l5 screw only.The l5 was cut out during fasting the l4 by 12n.An additional screw hole was created at another level other than l5.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
• 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: 6125368
• Report Number: 3005525032-2016-00149
• Device Sequence Number: 358120
• Product Code: MNI
• UDI-Device Identifier: 04546540562340
• UDI-Public: (01)04546540562340
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2017

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 Catalogue Number: 482317540
• Device Lot Number: B61337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 12/05/2016; 02/24/2017
• 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: Other