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

Catalog Number A1059

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Laceration(s) (1946); No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, a (b)(6) male patient was placed on a a1059 mayfield modified skull clamp for a posterior cervical decompression procedure; it is standard practice for this type of procedure to flex and translate dorsal the head in order to extend or open the interlaminar space for the decompression.During the case it was felt that the mayfield skull clamp may have moved so the procedure was stopped and the mayfield skull clamp position was revised but at the end of the case the surgical team found that there was a 1 - inch scalp laceration due to movement of one of the pins.There was no delay in surgery due to the product problem.Treatment of the laceration was not provided at this time.Additional information has been requested.

Manufacturer Narrative

Additional information received from the customer on 05feb2016.The a1059 mayfield skull clamp was in use for 10 years prior to this event occurrence.Stereotaxy equipment was not used at all to perform the surgery.The skull pins used were the integra brand adult reusable skull pins.The 1 inch scalp laceration was treated with a suture closure and the patient's outcome was good and without any major complications.

Manufacturer Narrative

Integra has completed their internal investigation on 18 mar 2016.The investigation included: methods: evaluation and repair of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: this device was received for repair only as such a specific assessment for slippage was not performed.The unit received had the lock having both rotational and lateral movement and a residue buildup present.Upon disassembly the repair team noted the lock needed new components added to replace worn internal parts; the unit also needed to be machined to have heli-coils added to large starburst threads; the set screw in the swivel base was tight also.The device was serviced and shipped back to this customer within specification.The dhr review has been deemed satisfactory.Date of manufacture: jun 30 2013.The dhr reviewed 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.No service history is on file for this device.No trend has been identified.Conclusion: no root cause could be determined.This device was serviced and shipped back to the customer within specification.

• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5360877
• MDR Text Key: 35696210
• Report Number: 3004608878-2016-00007
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2013
• 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
• Patient Age: 72 YR