MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.441 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number SD800.441

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on an unknown date, two (2) psi peek implants, an unknown number of unknown plates, and an unknown number of unknown screws, had to be removed due to infection.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This report is for one (1) psi sd800.441 peek implant.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Gender/sex.Updated event description.Initial reporter - occupation: initial reporter.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

4/30/2019.Updated event description: it was reported that on an unknown date, the patient underwent revision surgery of two (2) psi, an unknown number of unknown plates, and an unknown number of unknown screws due to infection.There were no fragments generated.There was no surgical delay.The procedure successfully completed.Patient outcome was unknown.This complaint involves an unknown number of devices.

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.A device history record (dhr) review was conducted: part number: sd800.441 (sd800.433), lot number: h807364 (h807365), part manufacture date: 01/03/2019, manufacturing location: brandywine, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history records of both lots revealed no complaint related anomalies.The device history records show that both peek components involved with the 2-piece psi implant were processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.A review of the raw material device history record revealed both lots met all specifications with no nonconformance noted.The raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Both lots involved met all dimensional, visual and packaging criteria at the time of release with no issues documented during manufacture 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.

• Brand Name: PSI SD800.441 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8455769
• MDR Text Key: 139992417
• Report Number: 2939274-2019-57131
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065120
• UDI-Public: (01)10887587065120
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD800.441
• Device Catalogue Number: SD800.441
• Device Lot Number: H807364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention