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

Catalog Number UNK_SPN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

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 one patient experienced loss of correction due to an infection.It is not known which implants these patients were implanted with or if revision surgery was performed.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 injury of loss of correction.

Manufacturer Narrative

The article '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) 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.An hcp was consulted regarding similar incidents reporting infections and stated that post-operative infections are a well known complication of spinal surgery and that they are the result of contamination of the surgical site.There is no information suggesting that a stryker device caused or contributed to the infection.

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 one patient experienced loss of correction due to an infection.It is not known which implants these patients were implanted with or if revision surgery was performed.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 injury of loss of correction.

• Brand Name: UNKNOWN
• 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: 12562962
• MDR Text Key: 274916740
• Report Number: 0009617544-2021-00194
• 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): Other