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

Catalog Number A1059

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 02/02/2017

Event Type  Injury  

Event Description

This is the first of 3 reports (similar products, similar product issue, different patients).There was slippage or movement of a skull clamp during the surgical procedure.Laceration reported.Additional information has been requested.Linked to mfg report numbers 3004608878-2017-00052, 3004608878-2017-00053.

Manufacturer Narrative

Sus reports received from fda on 21feb2017: sus# mw5067751, a1059 mayfield with event date (b)(6) 2017.Sus# mw5067752, a1059 mayfield with event date (b)(6) 2017.Both reports had the same event description of: patient's head slipped from 3 point traction of mayfield and suffered a head laceration which required staples.Request for additional information and clarification was sent to customer but to date, no new information has been received.

Manufacturer Narrative

Integra has completed their internal investigation on 03/08/2017.The investigation included: a dhr review cannot be performed at this time as the lot number was not provided nor was the product sent in for inspection.This review will take place once either or has been provided.No manufacturing or design related trend has been identified.Conclusion: in summary - the device was not released for evaluation therefore the root cause to the end users experience could not be determined.Due to the nature of this reported failure the mayfield patient positioning for success chart has been provided.

Manufacturer Narrative

Additional information received from customer on 05apr2017: the patient underwent a posterior cervical fusion for a cervical spine stenosis.The surgery was not performed with a stereotaxy device.Disposable integra adult size skull pins (a1072) were used.Lot number was unknown.The skull pins are not available to be returned for evaluation.As per surgeon, 60 pounds of pressure was applied on the skull clamp.The patient was positioned prone and was not repositioned during the surgery.The mayfield 3 point fixation device slipped during the case.The patient incurred a 2 inch long by 0.5 inch deep laceration on the side of the head.It is unknown if the device will be returned to integra for evaluation; risk management director at the user facility has yet to decide.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6348992
• MDR Text Key: 67952595
• Report Number: 3004608878-2017-00051
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/08/2017; 04/04/2017; 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 55 YR