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 Problems Hematoma (1884); Laceration(s) (1946)

Event Date 02/06/2020

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 physician reported that on (b)(6) 2020, the a3059 mayfield composite series skull clamp slipped during a cerebellum tumor surgery.The patient sustained a small laceration and hematoma that needed treatment.The physician reported that the injury could have been caused by having more pressure to the skull pins, and as the pressure was relieved, the skull clamp was not tightened down.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6, h10.Udi # (b)(4).The reported complaint was not confirmed as the product was not returned for evaluation.No dhr review was possible as no other lot or serial number was provided during the course of the complaint investigation.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 10278376
• MDR Text Key: 203903953
• Report Number: 3004608878-2020-00117
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1