MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Model Number	A2114
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
Medwatch uf/ importer report # (b)(4) was received with the following information: "during turning the patient to the prone position on the jackson table, the mayfield radiolucent headframe came unlocked.The pins that attached the headpiece to the patient's head came undone causing a laceration to the patient's head and the scrub tech's hand.Fortunately, the surgeon was supporting the patient's head during the occurrence, so no more injury was cased to the patient.This was after the headpiece had been sent out to the manufacturer a fourth time for repair.What was the original intended procedure? c1-c2 posterior fusion".Additional information has been received from the facility as follows: please provide the size of the laceration: about 4 inch laceration.Was there a delay in surgery due to product problem? if yes, how long? it caused a 30 minute delay in the case while we were changing or beds.Is the device available for evaluation? device is in my office for evaluation.
Additional Manufacturer Narrative
Additional information: 1.Will product be returned to integra for evaluation? the rep is going to pick it up when the new one comes in.2.What medical intervention was made to the patient after the laceration? the laceration was stapled, and a bandage was placed at the end of the case.3.Please provide patient outcome.I do not know the outcome after that.Investigation findings: mayfield infinity xr2 skull clamp (a2114) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; however, it does not appear to be a valid serial number for product a2114.The definite root cause cannot be determined.However, based on the reported complaint, probable root cause is improper or suboptimal placement of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Common Device Name: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15827478
• Report Number: 3004608878-2022-00245
• Device Sequence Number: 6156921
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: A2114
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male