MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown unk - constructs: uss/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn.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

Device report from synthes reports an event in germany as follows this report is being filed after the review of the following journal article: rushton, pishnamaz, m.Et al (2015), open versus percutaneous stabilization of thoracolumbar spine fractures: a short-term functional and radiological follow-up, journal of orthopedic surgery and traumatologiae cechoslovaca, vol.82(4), pages 274-281 (germany).The purpose of this prospective single-centre (level 1) cohort study is to compare the functional and radiological outcome between patients with thoracolumbar spine fractures treated either with open or percutaneous dorsal instrumentation one year after trauma.Between may 2010 and may 2012, a total of 72 patients underwent open or percutaneous dorsal instrumentation.Open group consisted of 43 patients (22 male and 21 female) with a mean age of 50.4 years treated with a conventional medial dorsal approach with the universal spine system (uss 1; synthes) while percutaneous group (competitors device) consisted of 29 patients (13 male and 16 female) with a mean age of 53.1 years.Follow-up was done at 1-year.The following complications were reported as follows: 4 patients had revision.A total of 9 screws fulfilled the radiological criteria for screw correction; however, missing clinical correlation and reduced general health status resulted in correction of only two screws in 1 patient following an open stabilization.2 cases for type c1 need revision according to accuracy of pedicle screw positioning.6 cases for type c2 need revision according to accuracy of pedicle screw positioning.3 patients had implant failure with progressive loss of reduction requiring elongation of the instrumentation was observed.This report is for an unknown synthes universal spinal system (uss).This impacted product captures the following adverse event.Screw correction type c1 need revision, type c2 need revision , patients had revision.This report is for one (1) unk - constructs: uss.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional information provided for reporting.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Omit 3134 and replace with 2993 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.

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8520839
• MDR Text Key: 142194533
• Report Number: 8030965-2019-62852
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention