MAUDE Adverse Event Report: ALPHATEC SPINE INCORPORATED BLADE C-C 70MM; RETRACTOR

Model Number 269-100-20

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/26/2021

Event Type  malfunction  

Event Description

Small fragment of instrument came off in the incision area of the patient wound.The fragment could not be retrieved.The fragment was seen and left in the soft tissue area, not in the neuro structure.Fda safety report id # (b)(4).

• Brand Name: BLADE C-C 70MM
• Type of Device: RETRACTOR
• Manufacturer (Section D): ALPHATEC SPINE INCORPORATED
• MDR Report Key: 11273290
• MDR Text Key: 230701183
• Report Number: MW5099196
• Device Sequence Number: 1
• Product Code: GAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 269-100-20
• Device Catalogue Number: 269-100-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR