MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03828645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a broken xia deformity reduction long arm monaxial screw.The screw was noted to be implanted very deep and it was determined that removing it would cause harm to the patient.Therefore, the screw was left implanted in the patient's bone.
Additional Manufacturer Narrative
Corrected data: changed b.2 from no selection to required intervention to prevent permanent impairment/damage (device).Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: the surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged.As a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.Patients who smoke have been shown to have an increased incidence of non-unions.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.Patients who are overweight may be responsible for additional stresses and strains on the device which can speed up metal fatigue and/or lead to deformation or failure of the implants.Once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidated.This may result in further side effects or necessitate the early removal of the osteosynthesis device.It is likely that the length of implantation (over 1 year) contributed to the event.Non fusion can cause the implant to be subjected to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.If the patient fused, these devices serve no functional purpose and can be removed.Other possible root causes include improper screw hole prep, overtightening of the blockers, and/or poor fixation construct.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a broken xia deformity reduction long arm monoaxial screw.The screw was noted to be implanted very deep and it was determined that removing it would cause harm to the patient.Therefore, the screw was left implanted in the patient's bone.
Additional Manufacturer Narrative
Correction to date received by manufacturer.The original awareness date was 10/29/2019, not 10/22/2019.Therefore, the initial emdr was submitted on time.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a broken xia deformity reduction long arm monoaxial screw.The screw was noted to be implanted very deep and it was determined that removing it would cause harm to the patient.Therefore, the screw was left implanted in the patient's bone.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9372080
• Report Number: 0009617544-2019-00124
• Device Sequence Number: 16788882
• Product Code: NKB
• UDI-Device Identifier: 07613154407644
• UDI-Public: 07613154407644
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2019

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: 03828645
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 12/09/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/04/2019; 12/27/2019
• 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: Required Intervention
• Patient Age: 29 YR