MAUDE Adverse Event Report: OSSUR BAYREUTH LINER PROTECT 3C 28 MTRX 10; PROSTHETIC LINER

Model Number MC97128

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Product evaluation ongoing - will follow-up with a supplemental report to include product evaluation.

Event Description

Below knee amputee patient was wearing a protect prosthetic liner and claims the pin came loose from the liner causing him to fall resulting in a broken foot on his sound side.

Event Description

Below knee amputee patient was wearing a protect prosthetic liner and claims the pin came loose from the liner causing him to fall resulting in a broken foot on his sound side.

• Brand Name: LINER PROTECT 3C 28 MTRX 10
• Type of Device: PROSTHETIC LINER
• Manufacturer (Section D): OSSUR BAYREUTH; logistigpark 7a; bayreuth 95448 ; GM 95448
• Manufacturer (Section G): OSSUR BAYREUTH; logistigpark 7a; bayreuth 95448 ; GM 95448
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6761286
• MDR Text Key: 81636990
• Report Number: 3006221031-2017-00001
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC97128
• Device Catalogue Number: MC97128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• 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 Age: 78 YR
• Patient Weight: 80