MAUDE Adverse Event Report: OTTOBOCK SE&CO. KGAA LAMINATION BAR

Model Number 17LS3=16-T

Device Problem Fracture (1260)

Patient Problems Abrasion (1689); Fall (1848); Bone Fracture(s) (1870); Hematoma (1884)

Event Date 07/08/2022

Event Type  Injury  

Manufacturer Narrative

The 17ls3 lamination bar was not sent to ottobock even though it was requested several times.A technical evaluation is therefore not possible on our part.32.475 of this item have been sold since january 2019.To date, 20 complaints have been received from this period.The present case is the fifth complaint with a breakage in the finished orthosis as the cause, but the first with a serious injury.Due to the low complaint rate, we consider this serious incident to be an isolated case.This assumption is also supported by the use of both manufacturing and design documents.Furthermore, the article complained about is already 4 years old and has exceeded its lifetime of 3 years.Further use does not correspond to the specifications in the instructions for use.Should the article nevertheless arrive with us, the technical evaluation will be carried out.In the event of new / different findings we will inform you.

Event Description

The patient wears a kafo (knee-ankle-foot orthosis, left leg) due to polio.She fell during a stay in turkey after the lamination bar (component of the orthosis) broke.The health effects were a fracture of the thumb, haematomas, severe pain and abrasions.A general examination and x-ray of the thumb followed by a plaster cast (outpatient) were performed on site.

Manufacturer Narrative

(b)(4) of the item 17lk3 have been sold since january 2019.To date, 20 complaints have been received from this period.The present case is the fifth complaint with a breakage in the finished orthosis as the cause, but the first with a severe injury.The 17ls3 lamination bar was sent to ottobock late.The fracture surface analysis has shown that the material meets the specifications (no cavities or material inclusions).The fracture surface of the lamination bar indicates that the material is overloaded.It is divided into a permanent fracture area of approx.65 % and an area of forced fracture of approx.35 %.On the basis of the number of lines of rest, it can be seen that the permanent breakage developed over a longer period of time.Due to the low complaint rate, we consider this serious incident to be an isolated case.This assumption is also supported by the use of both manufacturing and design documents.Furthermore, the article complained about is already 4 years old and has exceeded its lifetime of 3 years.Further use does not comply with the specifications in the instructions for use.

Event Description

The patient wears a kafo (knee-ankle-foot orthosis, left leg) due to polio.She fell during a stay in turkey after the lamination bar (component of the orthosis) broke.The health effects were a fracture of the thumb, haematomas, severe pain and abrasions.A general examination and x-ray of the thumb followed by a plaster cast (outpatient) were performed on site.

• Brand Name: LAMINATION BAR
• Type of Device: LAMINATION BAR
• Manufacturer (Section D): OTTOBOCK SE&CO. KGAA; max naeder str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer (Section G): OTTOBOCK SE & CO. KGAA; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer Contact: dominik schmidt ; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• MDR Report Key: 15967670
• MDR Text Key: 305342957
• Report Number: 9616494-2022-00006
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17LS3=16-T
• Device Catalogue Number: 17LS3
• Device Lot Number: 0001201841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 55 KG