MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: AXON; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: bauman, j.A., hardesty d.A., heuer g.G., and storm, p.B., (2011), use of occipital bone graft in pediatric posterior cervical fusion: an alternative paramedian technique and review of the literature, journal of neurosurgery pediatrics, vol.7 (xx), page 475-481 (usa).The aim of this study is to describe the authors¿ experiences in a pediatric population.Over a 4-year period, a total of 12 patients (5 male and 7 female) underwent occipital bone graft harvest for fusion augmentation with posterior cervical or occipitocervical fixation.The median age was 13 years (range 1.5¿19 years).This study was treated with axon (synthes) and the mountaineer (depuy spine).The median clinical follow-up was 14.5 months, and the median ct imaging follow-up was 7.5 months.The following complications were reported as follows: 1 patient developed an erosion of the occipital bone from a c1 screw due to cranial settling, however this occurred in an area remote from the craniectomy site and did not require revision.1 patient required a blood transfusion however, this was not due to bleeding at the graft harvest site.This report is for an unknown synthes axon.A copy of the literature article is being submitted with this medwatch.This report involves one unk - screw/rod construct acc: axon.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.This report is for an unknown screw/rod construct acc: axon/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: AXON
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15759777
• MDR Text Key: 303319962
• Report Number: 8030965-2022-09537
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention