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

Model Number A1059

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that a surgeon felt that the mayfield modified skull clamp (a1059) slipped and was not holding properly during a c2-c5 posterior cervical decompression and fusion procedure.There was an unspecified minor delay with no patient injury reported.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the lock had rotational movement and a residue buildup was present.Upon disassembly, it was noted that the index knob and the lock needed new components to replace worn internal parts; unit was machined to have heli-coils added to large starburst threads.New components were added to replace worn internal parts, and general cleaning and maintenance were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Service & repair could not duplicate slippage.The clamp had minor rotational movement in the locked position, but when properly positioned and put under pressure, the clamp would not have slipped.Probable root cause of the reported complaint is improper or suboptimal positioning of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Medwatch report# 4401610000-2023-8001 was received on 25jan2023 with the following information: "during the procedure, the surgeon stated that the mayfield skull clamp slipped.After the procedure was completed, a laceration was noted at the location of one of the mayfield skull clamp pins.The surgeon applied stitches to the laceration.The patient was taken to recovery.No other untoward patient effects.Integra would like to have the device returned for evaluation." what was the original intended procedure? : c-2-c5 posterior cervical decompression and fusion what problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do date of event: (b)(6).Dat of report: 01/2023.

• 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
• 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: 16114306
• MDR Text Key: 308583556
• Report Number: 3004608878-2022-00295
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• 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 Age: 62 YR
• Patient Sex: Male