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

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

Patient Problems Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369)

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 had an additional l5¿s1 fusion was performed 13 months after an l4¿l5 fusion because of persisting pain.There was one deep infection of the posterior wound, which was managed successfully by debridement and antibiotic treatment.The translaminar screws were left in place.1 patient developed leg pain due to stenosis of the lateral recessus of root l3, after l3-l4 fusion.10 months after primary surgery, the lateral recessus was decompressed.The segment was manually tested and proved to be solidly fused.2 patients, a second look was performed because of persistent pain, and the translaminar screws were removed.In both cases, the arthrodesis was found to be solidly fused.One of these patients developed an infection after screw removal, which healed after debridement.1 patient developed a dorsal wound infection, which was debrided.During reoperation, the arthrodesis was tested.L5-s1 was fused, and l4-l5 was not fused.Finally, renewed dorsal fixation was performed.In this patient, subsidence of both cages were observed on the radiographs, and radiolucencies were seen around the cage at l4-l5.This case was considered to be a nonunion.Although subsidence was observed in 7 of 71 levels, all in the two-level group, in only one case was there also a radiolucent zone around the cage.During surgical exploration, this level was tested, and a pseudarthrosis was found.This report is for an unknown uss pedicle screw.This is report 4 of 6 for (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: USS
• 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: 9536184
• MDR Text Key: 188483897
• Report Number: 8030965-2019-71574
• 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

• Date FDA Received: 12/31/2019
• 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: 12/06/2019
• 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