MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT: CRANIOS REINFORCED: TRAUMA; METHYL METHACRYLATE FOR CRANIPLASTY

Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed after the review of the following journal article: hwa t.P., et al (2022) comparison of outcomes of surgical repair of spontaneous temporal bone csf leaks and encephaloceles using bone cement and autologous material, otol neurotol volume 43 no.4, pages 500¿505 (usa).This retrospective study aims to report outcomes in transmastoid repair of middle fossa csf leak repair using three categories of repair materials: bone cement alone (bc), autologous materials (am), and combined materials (cm) using both autologous materials and bone cement.Between 2014 and 2020, all adults undergoing transmastoid repair of spontaneous middle fossa csf leak and/or encephalocele were identified.Forty-three adult patients met the criteria for inclusion, including 12 bone cement alone (bc) with 5 female patients, 15 autologous materials (am) with 9 female patients, and 16 combined materials (cm) repairs with 8 female patients.51% were female and 49% of defects were right-sided.The mean age at repair was 58.6 years.All subjects in this study underwent a transmastoid approach to middle fossa csf leak repair, with variation otherwise solely limited to the material used for repair of the site of the leak.For bone cement alone (bc) repair, craniostm hydroxyapatite bone cement was applied directly over the dehiscence and allowed to harden based on manufacturer recommendations.For anterior defects adjacent to the ossicles, gelfoam (pharmacia & upjohn company, kalamazoo, mi) was placed in the antrum to prevent any bone cement residue from affixing to the ossicles.For autologous materials (am) repair, the repair material varied by the surgeon and by case.The two most common repairs were with tragal cartilage graft underlay (surgeon a) and temporoparietal fascia graft underlay followed by placement of a shaped calvarial bone graft.In subjects with thin or previously harvested temporoparietal fascia, allograft material was employed in place of fascia, including duragen1 (integra lifesciences, princeton, nj) and alloderm1 (biohorizons implant systems, birmingham, al).For combined materials (cm) repairs, the repair material is varied by the surgeon.A calvarial bone graft followed by the application of craniostm was performed.A temporoparietal fascia graft underlay, calvarial bone graft, and lastly application of craniostm was performed by another surgeon.Performed a temporoparietal fascial graft underlay followed by application of craniostm was also performed by another surgeon.Follow-up (months) mean 37.9 (21 sd) for bc repair , (months) mean 59.2 (16 sd) for am repair and (months) mean 49.5 (24 sd) for cm repair.Reported complications: 1 recurrence in bone cement alone (bc) repair.The bc subject experienced primary surgical failure, with a persistent leak at the time of surgery, and underwent postoperative lumbar drainage with interval resolution within the same admission.The patient subsequently recurred once more, opted for a combined middle cranial fossa (mcf) and transmastoid approach to repair at an outside institution, and was subsequently lost to follow-up.1 recurrence in combined materials (cm) repair.The cm subject had initially undergone transmastoid with cm initially resolved but experienced delayed recurrence 3.5 years following the primary surgical repair.The patient underwent revision repair through a middle cranial fossa (mcf) approach.This report is for unk - biomaterial - cement: cranios reinforced: trauma.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown biomaterial - cement: cranios reinforced: trauma/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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.

• Brand Name: UNK - BIOMATERIAL - CEMENT: CRANIOS REINFORCED: TRAUMA
• Common Device Name: METHYL METHACRYLATE FOR CRANIPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15446189
• Report Number: 8030965-2022-07028
• Device Sequence Number: 15804047
• Product Code: LOD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown