MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; TAP, BONE

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

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - constructs: uss/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 at the time of filing this report.Investigation summary: 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: fleiderman, j., t al.(2008), results of surgical treatment of ao type-c thoracolumbar fractures, chilean orthopedics and trauma journal, vol.49, pages 71-78 (chile).The purpose of this investigation is to describe the clinical characteristics, management and progress of patients with work-related accidents, with ao type-c thoracolumbar fractures, who had surgery at the workers' hospital of santiago during a 10-year period, with 3-year follow-up at least.Between january 1994 and december 2004, a total of 64 patients (60 males and 4 females) were included in the study.The males had an average age of 35.6 years (18-63 years) and the females had an average age of 38 years (33-41 years).An unknown synthes universal spinal system was used in 58 patients while a competitor's device was used in 6 patients.The median follow-up was 58 months.The instrumentation was removed in 11 patients after a median of 15 months.The following complications were reported as follows: 1 patient had superficial infection.5 patients had deep infections.This impacted product captures the reported superficial infection, deep infections, cerebrospinal fluid fistula, hematoma, bursitis, lack of consolidation, progressed with chronic lumbar pain.3 patients had cerebrospinal fluid fistula.1 patient had hematoma.2 patients had bursitis.1 patient had lack of consolidation.2 patients progressed with chronic lumbar pain.1 patient had implant fracture.1 patient had a radicular injury because of an incorrectly positioned screw.This report is for an unknown synthes universal spinal system.This report is 1 of 3 for (b)(4).

• Type of Device: TAP, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8833493
• MDR Text Key: 152488743
• Report Number: 8030965-2019-66597
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention