MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: DENSACCESS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/ unknown lot.Part and lot number are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: fazzolari b et al.(2020), clinical and radiological outcome after minimally invasive surgical approach for type ii unstable odontoid fractures, neurochirurgie, volume 67, pages 350-357, (italy).The primary endpoint of our study is to evaluate the postoperative results of minimally invasive odontoid screw insertion in terms of outcome, fusion rate, and stability of cranio-cervical junction.The secondary endpoint was to investigate the influence of age or fractures¿ features on outcome and fusion rate.From july 2011 to february 2018, 38 patients (40 procedures) with unstable type ii fractures operated by a minimally invasive odontoid screw insertion technique were included in the study.There were 23 males and 15 females with a mean age of 66.3 years.The synthes dens access system was used in all cases.As the intended k-wire positioning is achieved, a synthes threaded bicortical screw is placed according to usual anatomical landmarks.Complications were reported as follows: 6 patients died of unrelated causes (3 myocardial infarction, 1 als, 1 pulmonary embolism, 1 accidental).Unknown patients had nonunion.2 underwent a second surgery by posterior approach.This report is for the unknown synthes threaded bicortical screw.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.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 - SCREWS: DENSACCESS
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12618219
• MDR Text Key: 276121619
• Report Number: 8030965-2021-08524
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 12/23/2021
• 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