MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report numbers 3004608878-2020-00514, 3004608878-2020-00516, and 3004608878-2020-00517.

Event Description

This is 2 of 4 reports.A patient safety analyst reported that since the fall of 2019 there have been four (4) scalp lacerations as a result of the mayfield headrest.One required staples to repair and others required manual pressure with bacitracin.Additional information received on 14aug2020 indicated that the patient undergone a posterior cervical fusion on (b)(6) 2020.The patient was initially positioned prone and the position was not changed during surgery.The patient suffered scalp laceration (unspecified) with unknown medical intervention.Patient was doing fine after the procedure.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Mayfield skull clamp was not returned for evaluation (repaired by the facility) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10513451
• MDR Text Key: 206296293
• Report Number: 3004608878-2020-00515
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1