MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE MCP SZ 30

Catalog Number SMCP-500-30-WW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the dhr for smcp-500-30-ww, cmr 174104t showed that no nonconformances were generated for the lot prior to release.The device was not returned for evaluation.As no unit has been returned and the exact failure is unknown, no failure analysis can be performed.The reported complaint was not confirmed.Based on the information, the root cause (and exact failure mode) is unknown.

Event Description

A physician reported that the silicone mcp (id: smcp-500-30-ww - sz 30 had a hardware failure.The unspecified case was performed on (b)(6) 2018.It was unknown if there was any patient injury, or surgery delay.Additional information has been requested.

• Brand Name: SILICONE MCP SZ 30
• Type of Device: SILICONE MCP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8907985
• MDR Text Key: 201251809
• Report Number: 1651501-2019-00038
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K022892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMCP-500-30-WW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1