MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; HEADLESS COMPRESSION SCREW

Model Number Screw, Headless Compression, 2.5mm x 10mm, Ti

Device Problems Inadequacy of Device Shape and/or Size (1583); Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

The instructions for use provide that the user selects the type and size of implant to best meet the patient's needs.It also state that the device is not designed to withstand the stress of weight bearing, load bearing, or excessive physical activity, and that device breakage may occur when the device is subjected to excessive loading associated with delayed union or nonunion.

Event Description

Broken screw post-op.

• Brand Name: SKELETAL DYNAMICS
• Type of Device: HEADLESS COMPRESSION SCREW
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: mehr malek ; 7300 n. kendall drive; suite 400; miami, FL 33156
• MDR Report Key: 11456582
• MDR Text Key: 243973538
• Report Number: 3006742481-2021-00002
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841506101835
• UDI-Public: 00841506101835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Screw, Headless Compression, 2.5mm x 10mm, Ti
• Device Catalogue Number: HCS-250XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: 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 Age: 53 YR