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

Catalog Number A1059

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Laceration(s) (1946); No Code Available (3191)

Event Date 07/12/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, there was an incident in the operating room involving the a1059 mayfield modified skull clamp attachments with respect to the open jackson beds.A (b)(6) male patient was in prone position undergoing a cervical laminectomy procedure.His head was secured to the mayfield skull clamp.As the surgical resident proceeded to attach the skull clamp to the open table adaptor, the patients head slipped from the mayfield attachment and his face hit the mayfield skull clamp.The incident caused a small superficial laceration and delayed the surgery by 20 minutes.The laceration was treated with topical bacitracin ointment and followed up by the surgical team.The patient had a good outcome.Adult disposable skull pins were used.The lot number and catalog number for these specific pins was not available.

Manufacturer Narrative

Integra has completed their internal investigation on 26 aug 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the complaint was not confirmed and no issues were observed.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.General maintenance and cleaning required.This device was manufactured on 08/23/2014 and a review of the dhr containing lot code 147 and serial number (b)(4) showed that this lot passed the required inspection points without mrrs or variances.There were 2 reworks.No manufacturing or design related trend has been identified.Conclusion: in summary we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements, however general maintenance is required.

• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5841645
• MDR Text Key: 51001911
• Report Number: 3004608878-2016-00200
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2014
• 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): Required Intervention
• Patient Age: 51 YR