MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: CMF; SCREW,FIXATION,BONE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - screws: cmf /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in israel as follows: this report is being filed after the review of the following journal article: rosenthal g, et al (2014), polyetheretherketone implants for the repair of large cranial defects: a 3-center experience, neurosurgery, volume 75, number 5, page 523-529, (israel).The objective of the study is to describe the experience with custom-made polyetheretherketone (peek) implants for the repair of large cranial defects in 3 institutions: san francisco general hospital (sfgh series), hadassah- hebrew university hospital (hadassah series), and the national neuroscience institute, singapore.Between 2006 and 2012, a total of 66 cranioplasties with peek implants were performed in 65 patients (46 men, 19 women, mean age 35 +/-14 years) for repair of large cranial defects were included in the study.The department of neurosurgery at 3 institutions participated in this study.In the sfgh series, 26 patients (23 men, 3 women) with a mean age of 38+/-13 years underwent 27 peek cranioplasties.In the hadassah series,16 patients (9 men, 7 women) with a mean age of 32+/-15 years underwent peek cranioplasty.In national neuroscience institute, singapore series, 23 patients (14 men, 9 women) with a mean age of 32+/-16 years underwent peek cranioplasty.All patients were implanted with an unknown synthes custom-made peek flap.The peek implant was secured to the skull with unknown synthes matrix self-tapping titanium screws and unknown synthes matrix miniplates.In patients with bulging of the brain prior to operation, a lumbar drain was placed to drain cerebrospinal fluid (csf) to assist in placement of the implant without undue pressure.If unexpected bulging of the brain occurred during surgery that interfered with good placement of the implant, moderate hyperventilation and/or mannitol were used to reduce brain swelling.A postoperative ct scan was obtained in all patients usually on the first postoperative day.Mean follow-up after peek cranioplasty was 24 +/-16 months (range, 6-60).Complications were reported: a total of 7 patients required placement of a ventriculoperitoneal shunt after cranioplasty for treatment of hydrocephalus.14 patients had temporal wasting as a concern that was at least mildly distressing.Sfgh series (usa): 2 patients died during follow-up of up to 5 years following cranioplasty.1 patient died after sustaining another severe traumatic brain injury (tbi) and another of an apparent drug overdose.3 patients had signs of infection at the peek cranioplasty site, necessitating removal of the implant.In all 3 patients the organism isolated from cultures was methicillin-resistant staphylococcus aureus (mrsa).1 these patients had a repeat peek cranioplasty that was successful and did not result in another infection or other complications.1 patient had an epidural collection that was drained without removal of the implant.1 patient was readmitted after cranioplasty with seizure.Hadassah series (israel): 1 patient had epidural empyema necessitating removal of the peek implant.The offending organism was mrsa.1 patient had a small subdural hematoma not requiring surgical intervention.1 patient presented with csf rhinorrhea 3 months after peek cranioplasty.An endoscopy with fluorescein was performed, but the site of leak could not be identified.The patient was treated with 1 week of lumbar drainage without recurrence of csf leak during 2 years of follow-up.National neuroscience institute, singapore series (singapore): 1 patient had an infection (mrsa) and had the peek implant removed.1 patient had a csf leak that required wound revision leading to wound breakdown over the implant and had the implant removed.1 patient had a postoperative epidural hematoma requiring surgical evacuation with retention of the peek flap.2 patients had seizures after cranioplasty.This report is for the unknown synthes custom-made peek flap, unknown synthes matrix self-tapping titanium screws and unknown synthes matrix miniplates.This report is for (1) unk - screws: cmf.This report is 2 of 3 (b)(4).

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11680845
• MDR Text Key: 246026804
• Report Number: 8030965-2021-03007
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention