MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the a3059 mayfield composite series skull clamp moved and caused an unspecified patient injury on (b)(6) 2020.After the patient was positioned and pinned, the unit allegedly moved, injuring the patient.The type of procedure was unknown.There was an unspecified revision or medical intervention done.The procedure was delayed for 55 minutes with no known adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

(b)(4).The device was not retuned for evaluation therefore the failure analysis and determination of root cause was not possible.The device history record (dhr) showed no abnormalities related to the reported failure.The reported complaint was not confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10288352
• MDR Text Key: 201882888
• Report Number: 3004608878-2020-00388
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1