MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - WASHERS; BOLT, NUT, WAHSER

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

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown washer/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.(b)(4).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: tonetti, j.Et al (2003), iliosacral screw placement with ultrasound-based navigation versus conventional fluoroscopy, techniques in orthopaedics, vol.18 (2), pages 184-190, doi: 10.1097/00013611-200306000-00007 (france).The aim of this study is to propose a ct-based navigation, using for the first time an ultrasound-based registration and clinical results are documented and compared with previous series of patients who underwent traditional fluoroscopic percutaneous surgery.A total of 34 patients were included in the study.Surgery was performed by percutaneous fluoroscopic screwing in 30 patients (23 male and 7 female) with an average age of 34.7 years (range, 17-60 y) using a cannulated screw ancillary (mathys inc, etupe, france).4 patients (1 male and 3 female) with an average age of 48.5 years (range, 34¿71 y) were instrumented with a cas using a 6.5-mm diameter screw for cancellous bones with 32-mm long threading and a washer (mathys inc., etupe, france).The follow up of the patients included radiographic evaluation at 3 months.The following complications were reported as follows: fluoroscopic group: 1 patient died.18 patients had postoperative neurologic deficit (7 patients with lesions of the lumbosacral trunk, 5 patients with s1 root lesions, 6 patients with cauda equina lesions).4 patients had peripheral action antalgic drugs, 7 patients with minor central antalgic, and 1 patient with major central antalgic.The postoperative ct scan control data of the fluoroscopic group found 12 misplaced screws.In 8 patients, the misplaced screws were on the anterior side.In 3 patients, the misplaced screws were crossing the s1 root foramen.In one patient, the wrong placement was both anterior and foraminal.In 4 cases, the screws were too short with negative ¿c¿ values.3 patients had loosening of the implanted screws.Cas group: 1 patient took central minor antalgic drugs.A (b)(6) year-old patient with poor mineralize bone had loosening of the implants.This report is for an unknown synthes cannulated screws, unknown synthes cancellous screws, and unknown synthes washers.This report is for one (1) unknown washer.This is report 1 of 2 for (b)(4).This complaint is linked to (b)(4).

• Brand Name: UNK - WASHERS
• Type of Device: BOLT, NUT, WAHSER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; 19380; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9871394
• MDR Text Key: 195093485
• Report Number: 8030965-2020-02193
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 03/24/2020
• 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