MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown uss construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between (b)(6) 1997 and (b)(6) 1998.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: laursen, m.Et al (1999), recombinant bone morphogenetic protein-7 as an intracorporal bone growth stimulator in unstable thoracolumbar burst fractures in humans: preliminary results, european spine journal, vol.8, no.6, pages 485-490 (denmark).The aim of this pilot study is to investigate the clinical use of recombinant human bone morphogenetic proteins-7 (rhbmp-7) in conjunction with a bovine bone-derived collagen type 1 carrier as a bone graft substitute in transpedicular transplantation of unstable thoracolumbar burst fractures.Between july 1997 to may 1998, a total of 5 patients (4 males and 1 female) were included in the study.These patients were treated with intracorporal op-1 transplantation, posterior fixation (universal spinal system - uss) and posterolateral fusion.Postoperative follow-up time was 12¿18 months.The following complications were reported: case 1 a (b)(6) year-old man had severe resorption at the site of transplantation.Case 2 a (b)(6) year-old man had the initial correction lost at follow-up, also the patient suffered from tiredness in his back, and at 12 months follow-up reported incidences of back pain.Radiographic evaluation revealed loosening of one screw which leads to instrumentation removal.Case 4 a (b)(6) year-old man during follow-up the correction was lost and compression at the fracture level increased beyond the pre-op value, also the patient often felt tiredness in his back.Case 5 a (b)(6) year-old woman during follow up had partly lost the correction.This report is for an unknown uss construct.This is report 4 of 4 for (b)(4).

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 8508739
• MDR Text Key: 141749897
• Report Number: 8030965-2019-62736
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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: 03/20/2019
• 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
• Patient Age: 60 YR