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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN OASYS SCREW; POSTERIOR CERVICAL SCREW SYSTEM
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STRYKER SPINE-US UNKNOWN OASYS SCREW; POSTERIOR CERVICAL SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problem Migration (4003)
Patient Problem Neuralgia (4413)
Event Date 02/15/2021
Event Type  Injury  
Manufacturer Narrative
'cervical decompression laminectomy and lateral mass screw-rod arthrodesis: surgical experience and analytical review of 4120 consecutive screws' in the british journal of neurosurgery, 2021 (https: //doi.Org/10.1080/02688697.2021.1887450).Device location unknown.
 
Event Description
The article 'cervical decompression laminectomy and lateral mass screw-rod arthrodesis: surgical experience and analytical review of 4120 consecutive screws' in the british journal of neurosurgery, 2021 (https: //doi.Org/10.1080/02688697.2021.1887450), was reviewed.Between december 2005 and december 2017, 695 patients underwent lateral mass arthrodesis using polyaxial screw and rod implants.Patient ages ranged from 14 to 75 years old with an average age of 52.8; 460 patients were male, 235 were female.Evaluation was conducted pre-operatively and the post-operatively at two months, one year, and five years.Patients were implanted with either oasys polyaxial screws and rods or non-stryker devices.Standard screws were 3.5 mm in diameter and emergency screws were 4 mm.Screws at subaxial levels were 12 to 16 mm in length and those used at c1 were 28 to 30 mm in length.Cross-links and subaxial lateral mass fixation were used in some cases.Of the total 4120 screws placed, 3998 were determined to be "appropriately positioned" using post-operative ct scan.There were no cases of rod breakage or migration and no patients had neurovascular injuries.Although specific device information is unknown, until receipt of information which dictates otherwise, post-operative device failures or serious injuries to which a device may have contributed, will be assumed to involve oasys devices.This report captures three patients who experienced "persistent c5 nerve root pain" and underwent revision surgery to address screws which had breached the intervertebral foramen and seven patients who experienced "malposition" of screws which required revision surgery.
 
Manufacturer Narrative
'cervical decompression laminectomy and lateral mass screw-rod arthrodesis: surgical experience and analytical review of 4120 consecutive screws' in the british journal of neurosurgery, 2021 (https: //doi.Org/10.1080/02688697.2021.1887450) the device was not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Per the oasys surgical technique: 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.¿ loosening of spinal fixation implants can occur.Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.¿ adverse effects may necessitate reoperation or revision.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.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.
 
Event Description
The article 'cervical decompression laminectomy and lateral mass screw-rod arthrodesis: surgical experience and analytical review of 4120 consecutive screws' in the british journal of neurosurgery, 2021 (https: //doi.Org/10.1080/02688697.2021.1887450), was reviewed.Between (b)(6) 2005 and (b)(6) 2017, (b)(4) patients underwent lateral mass arthrodesis using polyaxial screw and rod implants.Patient ages ranged from 14 to 75 years old with an average age of 52.8; (b)(4) patients were male, (b)(4) were female.Evaluation was conducted pre-operatively and the post-operatively at two months, one year, and five years.Patients were implanted with either oasys polyaxial screws and rods or non-stryker devices.Standard screws were 3.5 mm in diameter and emergency screws were 4 mm.Screws at subaxial levels were 12 to 16 mm in length and those used at c1 were 28 to 30 mm in length.Cross-links and subaxial lateral mass fixation were used in some cases.Of the total (b)(4) screws placed, (b)(4) were determined to be "appropriately positioned" using post-operative ct scan.There were no cases of rod breakage or migration and no patients had neurovascular injuries.Although specific device information is unknown, until receipt of information which dictates otherwise, post-operative device failures or serious injuries to which a device may have contributed, will be assumed to involve oasys devices.This report captures three patients who experienced "persistent c5 nerve root pain" and underwent revision surgery to address screws which had breached the intervertebral foramen and seven patients who experienced "malposition" of screws which required revision surgery.
 
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Brand Name
UNKNOWN OASYS SCREW
Type of Device
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 Key12558180
MDR Text Key274224086
Report Number0009617544-2021-00180
Device Sequence Number1
Product Code NKG
Combination Product (y/n)N
Reporter Country CodeJO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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