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

Catalog Number A1059

Device Problems Device Operates Differently Than Expected (2913); Mechanics Altered (2984)

Patient Problem Laceration(s) (1946)

Event Date 06/22/2017

Event Type  Injury  

Event Description

It was reported that the mayfield modified skull clamp (a1059) was released during a case and the patient was injured.Additional information was received on 13jul2017 and 17jul2017 from the customer with the following: on (b)(6) 2017, a (b)(6) female was undergoing a chiari decompression w/suboccipital decompression and c1 laminectomy procedure.As per the doctor ¿the pins were tightened to 60lbs then "handle" turned to "locked" position.When trying to flex neck to military tuck position, the posterior pin (on 2-pin side) slashed forward in scalp.So, likely the clamp wasn't/didn't remain engaged in skull as the arm hadn't been tightened yet.¿ no stereotaxy device was used.The length of time the product was in use before the event occurred was approximately less than 5 minutes.The posterior pin (on 2-pin side) slashed forward in the scalp on the left side of head, creating a laceration and breaking the skin.The laceration was stapled closed and betadine was applied.After the treatment of the laceration, the surgery proceeded.The mayfield clamp was removed from service immediately.Mayfield disposable skull (a1083 was used, lot number unknown).The pins are not available to be returned for evaluation.

Manufacturer Narrative

Investigation completed 8/9/2017.Device history record reviewed for serial number (b)(4) ,work order (b)(4) , lot number 117 a total of (b)(4) were manufactured on 8/19/2011 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points except for rejected product labels which were replaced.No service history is on file for this device.No manufacturing or design related trend has been identified.Post market information will continue to be monitored.Root cause could not determined at this time.This unit has been tested under pressure and when properly positioned.The slip could not be duplicated.The swivel base has some rotational movement while in the lock position.All other components were in good working order.The maintenance required would not result in the slip seen by the end user.

• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6733838
• MDR Text Key: 80751687
• Report Number: 3004608878-2017-00218
• 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,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• 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: 117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2011
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 59 YR