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

Model Number	48551000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
'mechanical implant failure in posterior cervical spine fusion' in the european spine journal, volume 21 (328¿334) 2012, was reviewed.
Event or Problem Description
This record captures a review of literature article "mechanical implant failure in posterior cervical spine fusion" from the european spine journal.The aim of this study was to determine whether the recent refinement and downsizing of the implants for posterior cervical fusion increase the occurrence of implant failure.One hundred forty-two consecutive cases of cervical fusion during a 12-year period from january 1998 to december 2009, using either cannulated magerl screws or a multiaxial pedicle screw¿rod system, were reviewed retrospectively after an average follow-up period of more than 3 years, and the rate and characteristics of the failure of these implants were evaluated.Forty one patients were implanted with oasys implants.It was reported that patient 5 experienced an oasys "screw disassembly" at c7 1 month post-operatively.Specifically, the oasys blocker migrated from it's respective screw as evident from x-ray imaging.Revision surgery was not performed as the patient remained asymptomatic.
Event or Problem Description
This record captures a review of literature article "mechanical implant failure in posterior cervical spine fusion" from the european spine journal.The aim of this study was to determine whether the recent refinement and downsizing of the implants for posterior cervical fusion increase the occurrence of implant failure.One hundred forty-two consecutive cases of cervical fusion during a 12-year period from january 1998 to december 2009, using either cannulated magerl screws or a multiaxial pedicle screw¿rod system, were reviewed retrospectively after an average follow-up period of more than 3 years, and the rate and characteristics of the failure of these implants were evaluated.Forty one patients were implanted with oasys implants.It was reported that patient 5 experienced an oasys "screw disassembly" at c7 1 month post-operatively.Specifically, the oasys blocker migrated from it's respective screw as evident from x-ray imaging.Revision surgery was not performed as the patient remained asymptomatic.
Additional Manufacturer Narrative
The article 'mechanical implant failure in posterior cervical spine fusion' in the european spine journal, volume 21 (328-334) 2012, was reviewed.Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.According to the oasys surgical technique: 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.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.With the available information, a root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: OASYS BLOCKER
• 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: 12562713
• Report Number: 0009617544-2021-00185
• Device Sequence Number: 11136604
• Product Code: NKG
• UDI-Device Identifier: 04546540371508
• UDI-Public: 04546540371508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 48551000
• Device Catalogue Number: 48551000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 12/19/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/18/2022
• 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 Age: 70 YR
• Patient Sex: Male