MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. CARPALFIX; BONE SCREW

Catalog Number 127-46616 AND 127-30222

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Non-union Bone Fracture (2369)

Event Date 05/26/2020

Event Type  Injury  

Event Description

It was reported that a carpalfix construct was removed due to incomplete fusion.Ct scans showed the implant loose.The implants were replaced with another company's parts.Doctor reported that he did not have a complaint with the system and was happy with the initial surgery.Implants not returned.

• Brand Name: CARPALFIX
• Type of Device: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; suite 410; parsippany, nj
• Manufacturer Contact: brian smekal ; 300 interpace parkway; suite 410; parsippany, nj ; 5888980898
• MDR Report Key: 10251273
• MDR Text Key: 198290473
• Report Number: 3007289093-2020-00014
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 127-46616 AND 127-30222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR