MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 22MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552322
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted in the patient.
Event or Problem Description
It was reported that during a revision scoliosis surgery three oasys polyaxial were discovered to be broken approximately 9 years post-operatively.The broken screws were left in the patient's vertebra.This report captures the first of the three screws.
Additional Manufacturer Narrative
Field d4 has been updated with the correct lot number.Visual, dimensional, material and functional analysis could not be performed as the device was discarded by the hospital.However, x-rays and images were provided.A review of the x-rays and images confirms that 3 of the 6 screws fractured post-op.Two x-rays were provided, one shows the patient prior to the revision.This x-ray indicates that the patient had 2 screws implanted unilaterally on the right side of the upper thoracic region, most likely t2-t3.The patient also had 4 screws implanted bi-laterally at t8-t9.No other implants noted.The second x-ray is post revision surgery.This second x-ray indicates that the t2 and t3 screws fracture and that the right t8 screw fractured as the shanks are seen still in the vertebral bodies.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported via follow up communication that the screws were discarded at the hospital and are not returning for inspection.The revision surgery was being performed due to the patients deformity progressing.The patient did not experience any trauma or accident.The device ous ifu was reviewed: "indications ¿ outside of the u.S.A (ous) & rest of world (row) when intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput ¿t3), the stryker spine oasys® system is indicated for: - degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)y, - spondylolisthesis, - spinal stenosis.- fracture/dislocation.- atlantoaxial fracture with instability.- occipito-cervical dislocation, - revision of previous spine surgery, - tumors -improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant.-while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials, which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors, which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.-stryker spine devices can only be used by doctors who are fully familiar with the surgical technique required and who have been trained to this end.The doctor operating must take care not to use the instruments to exert inappropriate stress on the spine or the implants and must scrupulously comply with any operating procedure described in the surgical technique provided by stryker spine.For example, the forces exerted when repositioning an instrument in-situ must not be excessive as this is likely to cause injury to the patient".The most likely cause of the reported event was determined to be multifactorial; all due to off label use and user error.Oasys is only indicated to be used from occiput - t3.It was used below t3 on this patient.Oasys is not indicated for deformity or pediatrics use ous.The patient was 12 years old and had scoliosis.It is unknown how severe the patients scoliosis was during the initial procedure in 2013, but it is likely that insufficient support was implanted based on the location of implants and degree of deformity noted.However, this could not be confirmed without an pre-op x-ray.
Event or Problem Description
It was reported that during a revision scoliosis surgery three oasys polyaxial were discovered to be broken approximately 9 years post-operatively.The broken screws were left in the patient's vertebra.This report captures the first of the three screws.

• Brand Name: OASYS 3.5 X 22MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14674737
• Report Number: 0009617544-2022-00063
• Device Sequence Number: 5502981
• Product Code: NKG
• UDI-Device Identifier: 04546540371720
• UDI-Public: 04546540371720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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 Model Number: 48552322
• Device Catalogue Number: 48552322
• Device Lot Number: 123459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female