MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Lot Number W1808188

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Event Description

During removal of the mayfield radiolucent skull pins, neurosurgical fellow noted retained particles left in left sided pin site.Fellow removed retained particles, pins placed into biohazard bag, manufacturer information recovered.No harm to patient.Manufacturer response for mayfield radiolucent skull pin, (brand not provided) (per site reporter).Unknown.

• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 9670518
• MDR Text Key: 177799961
• Report Number: 9670518
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: W1808188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6935 DA
• Patient Weight: 80