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

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A customer reported the mayfield composite series skull clamp (id a3059) slipped during an unspecified procedure causing patient incident (unspecified).There was no known delay in surgery.No other clinical information was provided.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h4, h6, h10.Unique device identifier (udi) : (b)(4).Mayfield skull clamp was returned for evaluation.Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was not confirmed from the evaluation of the returned product.No issues observed from the functional testing of the testing and the reported failure could not be duplicated.When unit is properly positioned and put under pressure unit would not have slipped.The observed condition is likely caused improper handling.The definite root cause cannot be reliably determined.

• 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: 10656970
• MDR Text Key: 210673721
• Report Number: 3004608878-2020-00591
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1