MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	UNK_SPN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Neck Pain (2433); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that 2 oasys screws in c1 have broken 8 months post-operatively.Revision surgery has not been reported.This report will capture the first of 2 screws.
Event or Problem Description
It was reported that 2 oasys screws in c1 have broken 8 months post-operatively.Revision surgery has not been reported.This report will capture the first of 2 screws.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analysis could not be performed as the device remains implanted in the patient.However, an x-ray confirms that both c1 screws fractured approximately halfway down the shaft of the screw.The screw fractures occurred at the cortical bone of c1.The similar fracture location on both screws potentially indicates an external event or that the patient's activity level may have contributed to the event, but this was not confirmed.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records could not be reviewed as a valid lot or catalog number was not provided and could not be obtained.The device stg was reviewed and the following information was found to be relevant: -the surgeon must warn the patient of the surgical risks and make the patient aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Surgeons must advise patients of this fact and warn of the potential consequences.For 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.In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.-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.The following list is representative, though not all inclusive, of the potentially adverse effects that the surgeon must consider whenever implanting a spinal fixation system or device: ¿ bending, disassembly or fracture of any or all implant components, ¿ fatigue fracture of spinal fixation devices, including screws, rods, and hooks has occurred, ¿ pain, discomfort, or abnormal sensations due to the presence of the device.Due to no product return and lack of product information, the root cause could not be determined conclusively.The duration of implantation most likely contributed to the event.Delayed healing and/or active implants after normal healing are known inherent risks.These risks may be amplified by the duration of implantation and/or poor bone quality, commonly observed in elderly patients.The patient's age may have contributed to the event, although it was reported the patient has no significant comorbidities.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• 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: 13543608
• Report Number: 0009617544-2022-00014
• Device Sequence Number: 3249059
• Product Code: NKG
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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 Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown