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

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

Patient Problems Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown universal spine system.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown universal spine system.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: hrabalek, l.(2012), the anterior extraperitoneal replacement of the intervertebral disk l5/s1¿safe solution for treatment of degenerative disk disease.Experience with 187 patients, global spine journal, vol.2(1) pages s-0032-1319892-s-0032-1319892 (czech republic) doi: 10.1055/s-0032-1319892.The aims of this study were to report prospectively the incidence and specific types of perioperative complications that occur with minimally invasive anterior retroperitoneal spinal surgery performed at level of the l5/s1 intervertebral disk.Between january 2001 to june 2011, a total of 187 patients (111 women and 76 men) average age of 45 years (range 24-76 years) were included in this study.Anterior lumbar interbody fusion was performed in 155 patients, including 96 patients with standalone fusion, 12 patients with concomitant anterior plating (oracle plate, synthes, usa) and 47 patients with additional posterior tp (transpedicular) fixation (uss, synthes, usa).Arthroplasty (tdr) was done in 32 patients.The following complications were reported as follows: 5 patients had weakness of the right abdominal wall postoperatively.9 patients had peritoneal opening without visceral injury intraoperatively.11 patients underwent posterior transpedicular fixation at l5/s1 segment for enhancement of the stability.This report is for an unknown universal spine system.This report is 2 of 2 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.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.Awareness date reported on previous follow up report as march 25, 2019 but should have been june 05, 2019.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, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8488654
• MDR Text Key: 141097230
• Report Number: 8030965-2019-62541
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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: 06/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention