MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD HEAD HOLDER; SKULLCLAMPS AND HEADREST SYSTEMS

Catalog Number XXX-HEADREST

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 06/04/2017

Event Type  Injury  

Event Description

Medwatch uf/ importer report # (b)(4).Patient in prone position in a mayfield head holder.At end of the procedure, the patient's left side of head in site had a two and a half centimeter laceration from the pin.The laceration was closed by staples.As per customer, the device was not going to be returned for evaluation.The customer stated that the device caused harm (laceration) but the more they looked at it, the less it looked like the device's fault.Additional information has been requested.

Manufacturer Narrative

Additional information received on 10jul2017: a (b)(6) year old female patient (gender verified by the customer), underwent a c1-c2 laminectomy posterior cervical spine (cyst removal and fusion).The device was placed on the patient and then the patient was turned for surgery.The surgery was not performed with a stereotaxy device.The pounds of pressure applied was not documented.The customer stated that the device was applied by an experienced neurosurgery attending (not a trainee).During surgery, the patient moved unexpectedly while under anesthesia and sustained a laceration.The patient had been stable on same anesthetic regimen for several hours when the event occurred.The length of time the product was in use before the event occurred was approximately 5 hours.They were unable to determine why the event occurred.Reusable skull pins were used.The skull pins are not available to be returned for evaluation.As per customer, the device and skull pins were not sequestered.The customer attributed the laceration caused by the device to the patient movement while under anesthesia.The device was returned to circulation.Integra investigation completed on 19jul2017: no dhr review could be completed at this time.No serial number or lot number was provided.No manufacturing or design related issues were confirmed.The root cause is undetermined at this time; the product was not returned for evaluation.

• Brand Name: MAYFIELD HEAD HOLDER
• Type of Device: SKULLCLAMPS 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: 6697227
• MDR Text Key: 79510252
• Report Number: 3004608878-2017-00210
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HEADREST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/25/2017
• 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
• Treatment: SKULL PIN
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 49