MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; SCREW, FIXATION, BONE

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

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Date 06/08/2011

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: song, k.J.Et al (2011), adjacent segment degenerative disease: is it due to disease progression or a fusion-associated phenomenon? comparison between segments adjacent to the fused and non-fused segments, european spine journal, vol.20, pages 1940-1945 (korea, south).The aim of this retrospective study is to determine whether fusion causes adjacent segment degeneration or whether degeneration is due to disease progression.Between february 1999 to march 2004, a total of 87 patients (54 male and 33 female) with a mean age of 54.4 years (from 38 to 67) underwent a single level anterior discectomy and fusion.Surgery was performed using a trocar (ao synthesis, diameter 7 mm) for harvesting of bone graft, then cages from competitor's device, and anterior cervical plate system (competitor's device) or the cslp (cervical spine locking plate, ao north america) system was used for anterior stabilization.The mean follow-up period was 84.8 months (from 62 to 121).The following complications were reported as follows: 38 of the 457 segments developed a radiological degenerative change: 28 of 174 segments in group a (the adjacent segment group), and 10 of the 283 segments in group b.4 patients developed new symptoms of degenerative disease; 2 cases in group a and 2 cases in group b.In two patients (one in each group) symptoms were relieved by conservative management, and in the other two symptoms responded to surgery.20 segments had progressions of anterior ossification formation (criteria ii): 15 in group a and 5 in group b.4 cases had and segmental instability (criteria iii) and had degeneration at fusion levels above.14 cases had progression of disc degeneration (criteria i): 9 in group a and 5 in group b.13 of these 14 cases had a preoperative degenerative condition of grade i or ii.On the other hand, 7 of 20 cases showed progression according to criteria ii, and these had no preoperative anterior ossification (grade 0); 6 of these 7 cases were in group a.This report is for an unknown synthes spine screws.This is report 2 of 2 for complaint (b)(4), it captures the adverse events of adjacent segment degeneration , calcification and ossification, joint instability, newly developed radiating and myelopathic symptoms (pain & numbness) and surgical intervention.

• Brand Name: UNK - SCREWS
• Type of Device: SCREW, FIXATION, BONE
• 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 ; 6103142063
• MDR Report Key: 9036336
• MDR Text Key: 161794725
• Report Number: 8030965-2019-68275
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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: 08/16/2019
• 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