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 04/21/2017

Event Type  Injury  

Event Description

It was reported that patient's head slipped.Additional information request was sent and on 17may2017, the following was provided by the customer: on (b)(6) 2017, a (b)(6) male patient was to undergo a posterior cervical laminectomy.No stereotaxy device was used.The patient was in the supine position during anesthesia induction.The mayfield clamp along with the integra adult disposable skull pins (a1083) was applied and the patient was then repositioned to prone.Shortly after, the mayfield was secured to the bed and it was noted that the patient¿s chin was becoming closer and closer to the chest.Inspection of the mayfield was done and the patient revealed a scalp laceration (location and length unknown).The locking knob on the mayfield that permits the 2 pin sites to turn was not holding.The mayfield clamp was removed and another clamp was used.The patient¿s scalp was stapled.Lot number of the skull pins were unknown.The skull pins are not available to be returned for evaluation.

Manufacturer Narrative

Investigation completed 5/25/2017.Method: dhr review, trend analysis, failure analysis.Device history record reviewed for product id: 134, work order / (b)(4) lot/ 134, serial (b)(4), manufactured on 04/30/2013 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.Prior service history: sr (b)(4), date 5/3/2016, reason: rotational and lateral movement and debris in mechanism.No manufacturing or design related trend has been identified.With respect to the returned unit, the lock has rotational movement when unit is not under pressure.Conclusion: root cause for this failure is improper setup based on the evaluation of our service group.When setup per the ifu and tested, the unit does not slip.Pm maintenance will be performed at this time.

• 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: 6575353
• MDR Text Key: 75445893
• Report Number: 3004608878-2017-00158
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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: 51 YR