MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI SD800.439 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.439

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Sedation (2368)

Event Date 03/14/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient specific implant didn't fit into craniotomy; it was too small on the apex-side.The surgeon solved the problem by using a mesh.This extended the procedure by over an hour.The outcome was not what the surgeon wanted and a reoperation will be necessary.The patient condition is reported as okay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record of part (b)(4), lot 8858499 showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

Additional narrative: an additional product development evaluation was completed: the patient specific implant (psi) device had a good fit into the 3d printed model of the patient¿s anatomy (pre-operative situation with bone void).The psi scanning protocol recommend scans of under 4 months old at date of psi request / data processing.This psi is within our time recommendation, and the surgeon does not believe the bone has resorbed.However, without a post-operative ct scan, there is no objective evidence available.Initially variable slice increment of the ct data was considered a potential root-cause for this complaint.However during further investigation, materialise has provided feedback that this psi model is not geometrically affected by variable slice increment.This is therefore not the root cause of the size discrepancy of the psi.As part of the ongoing investigation into the root cause of this complaint, the ct dataset was provided to materialise to be checked for obliqueness.The dataset used for the psi was confirmed as oblique.The other dataset (that did not conform to our scanning protocol) was confirmed as not oblique.A further investigation into obliqueness suggested that oblique ct data would generate an anatomical model that is too small, resulting in a psi that is too small for the defect.This can be confirmed in this specific case through a model comparison of the non-oblique ct scan with the oblique ct data.It can not be fully concluded to what extent an oblique ct dataset distorts a model.Based on the surgeon's feedback, it is unlikely that the root cause is due to bone resorption.No further actions can be taken if the cause of the event is a change in the patient¿s anatomy, without being provided a post-operative scan.Variable slice increment is checked on a case-specific basis, and has no impact on the result of the psi because it¿s discussed with and approved by the surgeon for every case where it exists.Variable slice increment did not affect the psi in this complaint.It can be confirmed that oblique ct data scans can cause geometric inaccuracy to anatomical models.However, it can not be confirmed that this is the root cause of this complaint without a comparison to an acceptable scan.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.

Manufacturer Narrative

Additional narrative: a product development evaluation was completed: the device had a good fit into the 3d printed model of the patient¿s anatomy (pre-operative situation with bone void).There were 4 datasets available within the received data package.The most appropriate scan according to the psi scanning protocol, was selected for the design of the patient specific implant.A post-operative scan was requested as part of the investigation but has not been provided, so it is unknown if the patient¿s anatomy had changed during the time between psi request and surgery.As part of the initial investigation into the complaint, a virtual 3d model comparison was performed.The 3d virtual anatomical models from the 4 datasets were checked against each other.The resulting 3d models showed dimensional differences.Based on an initial discussion with clinical engineers from provider of ct processing software (materialise mimics), it has been suggested that if the ct images are ¿oblique¿, this could affect the dimensional accuracy of the generated 3d model.However, it is unknown if the dataset used to design the psi contains ¿oblique¿ images, because it is not yet well defined how to identify ¿oblique¿ images within the current software used to process the ct data (mimics).No further actions can be taken if the cause of the event is a change in the patient¿s anatomy, without being provided a post-operative scan.Further investigation is required into the concept of ¿obliqueness¿ of ct scan data, and how to identify this within our software / process capabilities.Therefore, the cause of the complaint cannot be concluded or confirmed.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: PSI SD800.439 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3768098
• MDR Text Key: 4551245
• Report Number: 1000562954-2014-10057
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.439
• Device Lot Number: 8858499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 82