MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN INSTRUMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_SPN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Device location unknown.

Event Description

The article 'rigid occipitocervical fixation: indications, outcomes, and complications in the modern era' in the journal of neurosurgery: spine, volume 18 (333-339) 2013, was reviewed.One hundred consecutive patients were identified from 1997 onward, all of whom underwent rigid ocf either in a single stage (81 patients) or in two stages (19 patients).The mean patient age was 55 years (range 17¿93 years), with a sex distribution of 63 females and 37 males.The 3 major underlying etiologies were ra (41 cases), tumor (16 cases), and trauma (15 cases).The mean follow-up period was 44.2 months (range 6¿120 months).In ten cases, oasys instrumentation was used; in the other 90 cases non-stryker devices were used.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).This report captures one patient who experienced a vertebral artery injury on c-2 pedicle cannulation.The c-2 pedicle screw was successfully passed (contralateral c-2 screw was avoided) and there were no clinical sequelae.

Event Description

The article 'rigid occipitocervical fixation: indications, outcomes, and complications in the modern era' in the journal of neurosurgery: spine, volume 18 (333-339) 2013, was reviewed.One hundred consecutive patients were identified from 1997 onward, all of whom underwent rigid ocf either in a single stage (81 patients) or in two stages (19 patients).The mean patient age was 55 years (range 17¿93 years), with a sex distribution of 63 females and 37 males.The 3 major underlying etiologies were ra (41 cases), tumor (16 cases), and trauma (15 cases).The mean follow-up period was 44.2 months (range 6¿120 months).In ten cases, oasys instrumentation was used; in the other 90 cases non-stryker devices were used.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).This report captures one patient who experienced a vertebral artery injury on c-2 pedicle cannulation.The c-2 pedicle screw was successfully passed (contralateral c-2 screw was avoided) and there were no clinical sequelae.

Manufacturer Narrative

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.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.

• Brand Name: UNKNOWN INSTRUMENT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12478322
• MDR Text Key: 271650584
• Report Number: 0009617544-2021-00157
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/13/2021

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?: Yes
• 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: 09/02/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 11/13/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention