MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BIOMATERIAL - CEMENT: NORIAN: TRAUMA; FILLER, CALCIUM SULFATE PREFORMED PELLETS

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

Patient Problem Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - cement/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: gilardino, m., cabiling, d., bartlett, s.(2009), long-term follow-up experience with carbonated calcium phosphate cement (norian) for cranioplasty in children and adults, plastic and reconstructive surgery, vol.123, issue 3, pages 983-994 (usa).The purpose of the present study was to assess our long-term experience with norian used in pediatric and adult craniofacial reconstruction.Between 1998 and 2008, a total of 46 patients underwent cranioplasties using a norian (synthes, inc., west chester, pa.).For cranioplasties involving full-thickness cranial defects, our initial approach was the direct application of norian to the exposed dura.However, we modified this technique to involve interposition of resorbable mesh (rapidsorb; synthes) on the dura below the cranial bone to minimize fragmentation.Another implant used was a 3-0 prolene (ethicon, inc., somerville, n.J.).The study cohort consisted of 28 males and 18 females with an average age of 24.9 years (range, 4.3 to 78 years).Clinical follow- up ranged from 12.1 to 109.8 months, with an average of 43.9 months.The following complications were reported as follows: patient 1: a 6-year-old patient with a facial cleft was operated with inlay for full-thickness calvarial defect and an onlay with cranial bone graft for frontal bone irregularities.The patient had a spontaneous development of frontal and parietal fluctuant collections and wound breakdown.This patient had partial removal of infected norian and fragmented cement was noted.108 months without further complications.Organism: serratia marcescens (preoperative and intraoperative culture).Patient 2: a 15-year-old patient with cranial vault reshaping in infancy underwent an onlay.The patient had spontaneous development of draining collection over left eyelid this patient was treated with oral antibiotics for 6 weeks without improvement.This patient had complete removal of norian and fragmented cement was noted.There was moderate residual hollowing and the patient requested no further treatment.Organism: aureus (preoperative and intraoperative wound culture).Patient 3: a 13-year-old patient with cranial vault reshaping for slitventricle syndrome was operated with an inlay for full-thickness calvarial defect.The patient had asymptomatic fragmentation.This patient was reoperated on for additional contouring (not because of fragmentation).The norian was completely removed and replaced with fresh norian over interposed resorbable mesh (at 18 yr of age, see next entry).The same patient who was reoperated with inlay with norian at 18 years old had spontaneous development of drainage from the right temporal wound.There was no resolution with oral antibiotic therapy.The patient had complete removal of norian.There was a breach of the frontal sinus was noted when norian was removed in this area.The infection resolved.The patient did not return for further reconstruction.Organism: s.Aureus (preoperative and intraoperative wound culture).Patient 4: a 45-year-old patient with posttraumatic full-thickness calvarial defect had presented with swelling over left temple but without any signs of infection.It improved with oral antibiotics but reappeared 3 months later.The patient had complete removal of norian (purulence noted bilaterally).The rib grafts were viable and left in place.The patient has been followed for 15 months without further complications.Organism: preoperative aspiration cultures were negative; methicillin-resistant s.Aureus cultured intraoperatively.Patient 5: a 37-year-old patient with treacher collins syndrome was operated with onlay to bilateral malar regions and to forehead in conjunction with dorsal nasal cranial bone graft (fixated) had spontaneous development of fluctuance and erythema over forehead.The patient had oral antibiotics for 4 weeks.The patient had complete resolution and has been followed for 69 months without further complications.Organism: preoperative aspiration cultures positive for hemolytic streptococcus.Patient 6: a 46-year-old female patient with posttraumatic irregularities was operated with onlay to bilateral frontotemporal regions in conjunction with dorsal nasal cranial bone graft (fixated).The patient had trauma to forehead leading to hematoma that secondarily infected.The patient failed a course of oral antibiotics.The patient had complete removal of norian and was associated with purulence.The patient has been followed for 19 months without further complications.She has undergone fat grafting to the central forehead with excellent results.Organism: s.Aureus (preoperative and intraoperative wound culture).Patient 7: a 16-year-old patient who had radiation therapy for optic glicoma underwent onlay to bilateral temporal fossae and supraorbits for radiation-induced bony hypoplasia.The patient presented with progressive pain over right temporal and periorbital nregions with erythema and swelling.The patient had initial improvement with antibiotics but recurred with a draining wound.The patient had complete removal of norian at another institution.The patient was lost to follow-up after documented removal at another institution.Organism: preoperative aspirate negative.Patient 8: a 43-year-old patient with posttraumatic irregularities was operated with onlay to forehead and right supraorbital region.The patient had presented with chronic draining sinus through coronal incision.The patient was treated with subtotal removal of norian; only minor fragmentation noted at wound breakdown site.The patient had a recurrence of draining wound at another location 6 mo later and is receiving ongoing treatment.Organism: wound and intraoperative cultures negative.Patient 9: a 30-year-old patient with cranial vault reshaping in infancy was operated with onlay to contour calvarial irregularities.The patient had spontaneous development of swelling but no signs of infection.The patient was treated with drainage of seroma and complete removal of fragmented norian.The patient had resolution of seroma and no further problems at 2-yr follow-up.Organism: preoperative aspirate negative.Patient 10: a 23-year-old patient with posttraumatic full-thickness calvarial defect was operated with inlay for full-thickness calvarial defect with titanium mesh.The patient presented with chronic draining sinus through scalp on side of reconstruction.The patient was treated with subtotal removal of norian; only minor fragmentation noted at wound breakdown site; titanium left in place to protect underlying brain.The patient had resolution of wound issues; residual hollowing over titanium mesh.The patient was waiting further reconstruction.Organism: wound and intraoperative cultures negative.Patient 11: a 42-year-old patient with post craniotomy irregularities was operated with onlay to contour calvarial irregularities.The patient had spontaneous development swelling and erythema.The patient was treated with oral antibiotics for 4 weeks and the infection was resolved.The patient did not return for further follow-up.Organism: preoperative aspirate did not yield any specimen for culture.Patient 12: a 14-year-old male patient with hemifacial microsomia was operated with onlay to supraorbital rims, temporal fossa.The patient had spontaneous development of left temple swelling without signs of infection and returned 2 months later with erythema and skin breakdown.The patient was treated with complete removal of norian.The patient has been followed for 77 months without further complications; he has undergone reconstruction with cbg without issue.Organism: preoperative aspirate did not yield any specimen for culture.This report is for an unknown synthes norian cement and a resorbable mesh (rapidsorb; synthes).This is report 8 of 10 for (b)(4).The complaint involves 19 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4): this complaint will include 10 devices, 10 norian cemet (1st pc), (b)(4): this complaint will include 10 devices, 7 norian cemet(2nd pc).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - BIOMATERIAL - CEMENT: NORIAN: TRAUMA
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10502066
• MDR Text Key: 210377111
• Report Number: 2939274-2020-04006
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR