MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: CLICK'X; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK - MONO/POLYAXIAL SCREWS: C

Device Problem Break (1069)

Patient Problems Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws: click'x.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: seifen, t.Et al (2015), the value of 18f-fluoride pet/ct in the assessment of screw loosening in patients after intervertebral fusion stabilization, european journal of nuclear medicine and molecular imaging, vol.42 (2), pages 272-277 (austria).The aim of this study is to evaluate 18f-fluoride pet/ct in the diagnosis of screw loosening in patients with persistent or recurrent back pain after spondylodesis and to compare directly the results of this imaging modality with those of functional radiography, the standard imaging procedure to establish this diagnosis.A total of 59 patients (20 male and 39 female) with a mean age of 59.5±13.6 years had persistent or recurrent episodes of pain in the region of previous intervertebral fusion stabilization and therefore suspected of implant instability due to screw loosening.Previous surgery was performed using plivios cage, travios cage and click¿x screws.The final diagnosis was based on intraoperative exploration and a follow-up of 21 ¿ 36 months (mean 27.7 months) after 18f-fluoride pet/ct.The following complications were reported as follows: 8 patients with screw loosening had radiolucent zone surrounding screw shaft.1 of these was seen in the focal uptake at screw entry point, and 7 patients seen in the focal uptake at screw entry point and surrounding shaft.Revision surgery was recommended in 30 patients but only performed in 27 patients.1 patient did not give consent to revision surgery and to the other two patients, 1 did not undergo revision surgery due to a high risk of serious intraoperative complications and the other due to an acute inflammation.A (b)(6)-year-old male patient had a typical pattern of screw loosening at l4: increased uptake around the screw is shown on the 18f-fluoride pet/ct image which was confirmed during revision surgery.Additionally, increased tracer uptake associated with degenerative disease (pseudoartefacts) can be seen at l5 and s1.1 patient with screw loosening had screw displacement seen in the focal uptake at screw entry point and surrounding shaft.3 patients with screw loosening had screw breakage.2 of these was seen in the focal uptake at screw entry point and surrounding shaft, while 1 patient had no uptake.Of the 59 patients investigated, 20 (18 of 27 patients in the intraoperative exploration group, 2 of 32 during follow-up) were found to be positive for implant failure due to screw loosening.58 of 156 screws were intraoperatively proven to be positive for loosening.This report is for an unknown synthes click¿x mono/polyaxial screws.It captures adverse events of screw loosening with radiolucent zone surrounding screw shaft, screw loosening with revision surgery and acute inflammation.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: CLICK'X
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9219331
• MDR Text Key: 175658402
• Report Number: 8030965-2019-69522
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - MONO/POLYAXIAL SCREWS: C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2019
• 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