MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

Device Problem Fracture (1260)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information unknown.Date of event is unknown.This report is for an unknown rod/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.Explant date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: peru reported that a patient implanted with what a surgeon believes to be the click x system had a post-operative ultrasound of the area where the transpedicular system was placed.The tests and x-ray images showed possible fractures of the bars (rods).The patient was initially implanted with the device by another surgeon located in lima but will be scheduled for an explant of the possible click x system.The devices will be returned for investigation.A definite assessment cannot be made at this time as it is not confirmed that the implanted system was the click x.This report is for an unknown rod.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The rods were not returned.The investigation was completed based on the provided x-rays.Two x-rays were provided, a lateral view and a posterior view.The lateral view shows a potential break just above the lowest set of screws, in the s1 vertebrae, however this break cannot be confirmed as the quality of the images provided is poor, and the break is not visible in both x-ray views.The complaint condition could not be visually confirmed and could not be determined if it was consistent with the reported condition.No new malfunctions were 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

Is this a single use device was incorrectly checked in the initial report.It is unknown if the device was reprocessed and reused on the patient.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.

Event Description

It was further reported that patient did not return for the scheduled consultation with the doctor.The patient has not been revised and no additional surgeries have been scheduled at the time of reporting.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf PA 4436 ; SZ 4436
• MDR Report Key: 7399118
• MDR Text Key: 104452414
• Report Number: 2939274-2018-51469
• Device Sequence Number: 1
• Product Code: HSB
• 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: 03/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 06/08/2018
• Supplement Dates FDA Received: 04/27/2018; 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR