MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN

Model Number MSB_UNK_CENTRPIECE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Autoimmune Disorder (1732); Fever (1858); Unspecified Infection (1930); Myalgia (2238); Neck Pain (2433); Ambulation Difficulties (2544)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Tacconi.L., aquila, f.Cervical laminoplasty in the elderly: report of a single center experience and review of the literature.Neu roquantology.2020.18(7):16-25.Age/date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date that the article was accepted for publication as the event date was not provided in the published literature.Other relevant device(s) are: product id: ms b_unk_centrpiece, serial/lot #: unknown; product id: msb_unk_centrpiece, serial/lot #: unknown.Pma/520k: product identifier is unknown, hence 510k# is not available.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Cervical laminoplasty has become one of the most endorsed surgical techniques for the treatment of multilevel spondylotic myelopathy, especially in the elderly.It can avoid an extensive anterior neck surgery in any case where there is not a pre-existing kyphosis or evidence of abnormal spinal movement.It is a retrospective single centre experience with open-door laminoplasty for multilevel cervical myelopathy in an elder population.Among the 30 selected subjects, 2 showed surgical complications that required re-intervention.All the others 28 patients, with a minimum follow-up of 18 months, showed adequate decompression of the spinal canal at the post-operative mri, no persistent axial pain nor persistent postoperative complications.It discusses use of titanium miniplates (centerpiecetm plate fixation system, medtronic).Reported events: in every patient, an accurate preoperative clinical evaluation was performed.The same neurological assessment was performed as a follow-up at 6 and 18 months.In all patients, an ¿open-door¿ laminoplasty was performed.Under general anesthesia and in the prone position, all patients underwent a posterior median cervical incision centered to c3-c6 with a median length of 6 cm.The muscles were detached via a subfascial technique from the posterior arc of c3, c4, c5, and c6.Then we created bony grooves bilaterally on the lateral border of the laminae with a diamond drill and paying attention to avoid damaging the facet joints.The lamina was then elevated using the contralateral groove as a fulcrum on the intended side and then lifted in order to enlarge the canal.The lifted laminae were fixed to the ipsilateral articular masses using titanium miniplates (centerpiecetm plate fixation system, medtronic).In the last 7 cases, we began using an ultrasonic bone scalpel to perform the bony grooves.This device resulted in faster surgical times and a safer technique to preserve the integrity of the underlying dura mater.A rigid cervical collar was positioned in all patients for no longer than 24-36 hours.After this time, all patients promptly started physical therapy in the post-operative period with a median of 48 hours (range 36-72 hours).All were discharged or transferred to a rehabilitation center within a week.Driving was forbidden for at least 6 weeks.Results: two patients showed surgical complications: one presented fever and wound swelling two weeks after discharge.He had developed a post-operative deep wound abscess that required re-opening, removing of the plates and laminae, and a posterior lateral mass fixation.The second patient showed severe cervical mechanical pain three weeks after surgery with xray evidence of c3-c5 instability, consequently prompting posterior fixation surgery.One of these had a car accident after the end of the study (18 months from surgery) with consequent c1-c2 fractures that required posterior decompression and screw fixation.Another one, after a substantial neurological improvement, presented a clinical deterioration 28 months from surgery, in terms of diffuse and increasingly invalidating muscle pain.A muscle biopsy showed an autoimmune myopathy.All 28 subjects showed adequate decompression of the spinal canal in the post-operative mri, but only 19 patients showed a radiological improvement of the pre-operative alterations on t2 weighted-images of the spinal cord at the 18-month mri follow-up.

• Brand Name: UNKNOWN
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11869444
• MDR Text Key: 252143987
• Report Number: 1030489-2021-00687
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CENTRPIECE
• Device Catalogue Number: MSB_UNK_CENTRPIECE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR