MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	4823717540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that screw head dislodged from the screw shank during revision surgery.All broken fragments were retrieved and all screws were removed.Per the communication with rep., the patient fused and the revision surgery was for removing hardware.No adverse consequences to the patient was reported.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review.Result: the reported event was confirmed via correspondence with the rep.The device was not returned for evaluation as it was retained by the hospital.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The ifu states that "these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Metallic implants can loosen, bend, fracture, corrode, migrate, cause pain or stress shield bone." conclusion: as the device was not returned, a definite root cause cannot be determined.Based on information in the ifu, it is likely that due to the stresses and strains while being implanted, the screw tulip disengaged when force was applied to it during removal.
Event or Problem Description
It was reported that screw head dislodged from the screw shank during revision surgery.All broken fragments were retrieved and all screws were removed.Per the communication with rep., the patient fused and the revision surgery was for removing hardware.No adverse consequences to the patient was reported.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8237812
• Report Number: 3005525032-2019-00001
• Device Sequence Number: 2280040
• Product Code: NKB
• UDI-Device Identifier: 07613252045731
• UDI-Public: 07613252045731
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: Health Professional
• Device Catalogue Number: 4823717540
• Device Lot Number: B75227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR