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

Catalog Number A1059

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem Suture Abrasion (2497)

Event Date 04/01/2020

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 number 3004608878-2020-00296.

Event Description

This is 2 of 2 reports.A customer reported that the a1059 mayfield modified skull clamp was observed to have lost tension when drapes were removed at the end of a posterior fossa craniotomy procedure on (b)(6) 2020.It was observed that the clamp was no longer secured and the pin was disengaged.The patient's head slipped, causing a full thickness abrasion which required stitches.

Event Description

N/a.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The reported complaint was not confirmed via inspection of the item.The unit passed all specific functional testing requirements.No issues related to the reported complaint were observed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.The device exceeds its expected life of 7 years (manufactured in 2008).

• 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: 10280788
• MDR Text Key: 202720249
• Report Number: 3004608878-2020-00297
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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: A1059
• Device Lot Number: 081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SKULL PINS