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

Catalog Number A1059

Device Problem Detachment Of Device Component (1104)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

Patient was in a mayfield skull clamp and during turning of patient, the plunger at the bottom of the skull clamp completely came out which caused release of tension in the skull clamp and caused a laceration to the patient.Due to the plunger, they had to remove and get a new skull clamp to apply to the patient to do the procedure.Surgery delay was 20 minutes.Additional information has been requested.

Manufacturer Narrative

Additional information received from the customer on 09may2016: a (b)(6) male patient underwent a revision of the anterior cervical fusion, posterior cervical fusion fixation cervical 2 ¿ thoracic.No stereotaxy device was used during surgery.Integra adult disposable skull pins (product id: a1120, lot number unknown) were used.The skull pins are not available to be returned for evaluation.The patient was supine on the cart when the mayfield was applied.The intent was to turn prone from the cart to the bed.Pounds of pressure applied was unknown.The patient incurred a 4 cm skin laceration.The skin laceration treated with no further interventions.No other information was provided.

Manufacturer Narrative

Integra has completed their internal investigation on 28jun2016.The investigation included: the device was not returned for evaluation.The lot number of the device was not provided.The most likely lot numbers could be 079 (manufactured on december 31, 2007) or 061 (march 31, 2006).No service history is on file for these devices.No manufacturing or design related trend has been identified.In summary - the device was not released for evaluation therefore the root cause to the end user's experience could not be determined.

• 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: 5628869
• MDR Text Key: 44332818
• Report Number: 3004608878-2016-00102
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• 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: 74 YR