MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

There were 33 patients (24 males and 9 females) with an average age of 36 yrs (range, 24¿57 yrs) in the single group and 19 patients (12 males and 7 females) with an average age of 39 years (range, 25-55 yrs) in the double-level group.This report is for an unknown uss pedicle 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: pavlov, p.W.Et al.(2004), good outcome and restoration of lordosis after anterior lumbar interbody fusion with additional posterior fixation, spine, vol.29, number 17, pages 1893-1900 (netherlands).The aim of this study is to evaluate clinical performance of alif with syncage supplemented with posterior fixation, with special emphasis on the safety and efficacy of the surgical procedure and the ability to restore sagittal alignment, restore intervertebral height, and fuse the motion segment.Between october 1996 and february 1998, there were 33 patients (24 males and 9 females) with an average age of 36 yrs (range, 24¿57 yrs) in the single group and 19 patients (12 males and 7 females) with an average age of 39 years (range, 25-55 yrs) in the double-level group were treated with an intervertebral syncage (mathys ag bettlach, bettlach switzerland), 4.5-mm titanium screws (synthes, oberdorf, switzerland) and pedicle screws (universal spine system).The follow-up period was 4 years.The article did not specify which of the devices were being used to capture the following complications: 1 patient, 1 of the translaminar screws broke.10 months after primary surgery, a refixation was performed with a facet screw, and it was found that the motion segment was not fused.At the 2-year follow-up observation, there were no radiologic signs of nonunion.This report is for an unknown uss pedicle screw.This is report 5 of 6 for (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9536212
• MDR Text Key: 188676162
• Report Number: 8030965-2019-71575
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• 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