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); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

Event Description

Patient laceration when applying mayfield skull clamp a1059 was reported.The customer was not sure which specific a1059 skull clamp unit.Reusable skull pins were used.Additional information has been requested.

Manufacturer Narrative

Additional information received from the customer via email on 20jul2016: a (b)(6) female patient underwent a suboccipital craniectomy, c1 laminectomy, resection of intradural extramedullary mass.No stereotaxy device was used.The patient was positioned prone using mayfield.There was no repositioning during surgery.Mayfield pins was applied with appropriate pressure to punch through the topical skin to keep headpiece in place (3 clicks).While the patient was in prone, one of the surgeons was holding onto the headpiece with the pins already applied while another surgeon was connecting all parts of the mayfield together.At the time, one of the mayfield pins slipped and lacerated approximately 1cm length.A new mayfield headpiece with new pins were replaced and the surgeon noted that patient¿s head skin was oily, explaining the reason why the headpiece slipped.He tightened the second mayfield an extra click.The laceration was on the right side of head, approximately 1cm length, and pressure was applied to stop the bleeding and the skin was sutured closed with 4-0 monocryl absorbable suture.There was no surgery delay due to the issue reported.Surgery proceeded as planned.The patient was stable throughout surgery and was moved to neuro intensive care unit post procedure without complications related to the incident.The product will not be returned to integra as no equipment or pins malfunction occurred per surgeon.The lot code of the skull clamp was 154.The adult size skull pins are available to be returned for evaluation.

Manufacturer Narrative

Integra has completed their internal investigation on 08/16/2016.The product was not returned to integra for evaluation as no equipment or pins malfunctioned occurred per surgeon.Dhr review and trend analysis not required as product will not be sent in since it was reported that no malfunction occurred per this customer.In summary: root cause not determined since no product was returned.

• 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: 5800517
• MDR Text Key: 49754123
• Report Number: 3004608878-2016-00186
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2016

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: 154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/22/2016; 08/31/2016
• 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: 57 YR