MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317570
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left screw from lilac bone was being attempted to be removed.Holding the screw head during locked the outer tube of screw driver, attempted to lose the screw, however removed screw head only.Removed the remaining screw part in lilac bone using adjustment driver and complete to remove screw whole.Additional information received from sr by phone on 4-nov-2016.Implanted xia3(ilia) and es2(lumbar) both for fractures on (b)(6) 2015.And removed xia3 as planned on (b)(6) 2016.
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.It was confirmed that the patient fused.Conclusion: the plausible root cause of the xia screw tulip head disengagement is due to patient's fusion and excessive force required to remove the screw.
Event or Problem Description
It was reported that the left screw from lilac bone was being attempted to be removed.Holding the screw head during locked the outer tube of screw driver, attempted to lose the screw, however removed screw head only.Removed the remaining screw part in lilac bone using adjustment driver and complete to remove screw whole.Additional information received from (b)(4) by phone on (b)(6) 2016.Implanted xia3(ilia) and es2(lumbar) both for fractures on (b)(4) 2015.And removed xia3 as planned on (b)(6) 2016.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 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: 6122748
• Report Number: 3005525032-2016-00148
• Device Sequence Number: 786652
• Product Code: MNH
• UDI-Device Identifier: 04546540562395
• UDI-Public: (01)04546540562395
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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 Catalogue Number: 482317570
• Device Lot Number: B48274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60