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

Catalog Number UNK_SPN

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Paresis (1998)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

'complications of cervical pedicle screw fixation for nontraumatic lesions: a multicenter study of 84 patients' in the journal of neurosurgery: spine, volume 16 (238¿247) 2012, was reviewed.Device location unknown.

Event Description

This record captures a review of literature article "complications of cervical pedicle screw fixation for nontraumatic lesions: a multicenter study of 84 patients" from the journal of neurosurgery spine.The purpose of this study was to evaluate the peri- and postoperative complications of ps fixation for nontraumatic lesions and to determine the risk factors of each complication.Eighty-four patients who underwent cervical ps fixation for nontraumatic lesions were independently reviewed to identify associated complications.The mean age of the patients was 60.1 years, and the mean follow-up period was 4.1 years (range 6¿168 months).Seven different instrumentation systems were used, the oasys system was used in 43 patients.It was reported that 3 patients experienced nerve root injuries due to screw misplacement.Two of these cases involved penetration of the pedicle probe into the vertebral artery.Additional surgery for screw removal was performed in 2 patients with motor paresis (grade 2/5 in both cases) and replacement of a screw in 1 case only with sensory disorder.There were no further complications in these patients.In accordance with fda guidance issued 08 november 2016, because limited information is available about each reportable event, an individual mdr is being submitted for each device identified by distinct generic names (screw, rod, cage, etc.) and each event type (death, serious injury, malfunction).One report is being filed capturing the serious injuries involving oasys screws.

Manufacturer Narrative

The article 'complications of cervical pedicle screw fixation for nontraumatic lesions: a multicenter study of 84 patients' in the jounral of neurosurgery: spine, volume 16 (238-247) 2021, 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.The stryker surgical technique provides detailed steps on preparing pedicle pathways and inserting the screw.The stg indicates that using an incorrect tap or drill combination can result in reduced bone purchase.The surgeon should also be thoroughly familiar with the surgical procedure, instruments, and implant characteristics prior to performing surgery.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.

Event Description

This record captures a review of literature article "complications of cervical pedicle screw fixation for nontraumatic lesions: a multicenter study of 84 patients" from the journal of neurosurgery spine.The purpose of this study was to evaluate the peri- and postoperative complications of ps fixation for nontraumatic lesions and to determine the risk factors of each complication.Eighty-four patients who underwent cervical ps fixation for nontraumatic lesions were independently reviewed to identify associated complications.The mean age of the patients was 60.1 years, and the mean follow-up period was 4.1 years (range 6¿168 months).Seven different instrumentation systems were used, the oasys system was used in 43 patients.It was reported that 3 patients experienced nerve root injuries due to screw misplacement.Two of these cases involved penetration of the pedicle probe into the vertebral artery.Additional surgery for screw removal was performed in 2 patients with motor paresis (grade 2/5 in both cases) and replacement of a screw in 1 case only with sensory disorder.There were no further complications in these patients.In accordance with fda guidance issued 08 november 2016, because limited information is available about each reportable event, an individual mdr is being submitted for each device identified by distinct generic names (screw, rod, cage, etc.) and each event type (death, serious injury, malfunction).One report is being filed capturing the serious injuries involving oasys screws.

• 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 Key: 12562917
• MDR Text Key: 274290228
• Report Number: 0009617544-2021-00193
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 12/19/2021
• Supplement Dates FDA Received: 01/18/2022
• 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 Number: 1
• Patient Outcome(s): Required Intervention; Other