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

Catalog Number A1059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement when unit is not under pressure, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.Unit needed heli-coils added to large starburst threads.The device was manufactured in 2012.The reported complaint was not confirmed.Root cause was unknown however the most probable root causes are: incorrectly assembled device, improperly tested/inspected device, improper technique used during procedure, off-label use of device during procedure (user error), device used with incorrect/unauthorized devices/accessories for procedure.

Event Description

A customer reported that a a1059 mayfield modified skull clamp was used during a fusion spine decompression posterior cervical c3-6 procedure on a (b)(6) female patient on (b)(6) 2019.The patient incurred a deep laceration that required suturing.There was a delay in surgery due to the product problem.The patient was admitted postoperatively and discharge four days later.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8604451
• MDR Text Key: 144850028
• Report Number: 3004608878-2019-00107
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR