MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.440 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED NONALTERABLE

Model Number	SD800.440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
It was reported that on an unknown date, the psi peek implant had to be removed due to leakage.There was no reported issue with the device.The procedure outcome and patient status are unknown.Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown), plate (part: unknown, lot: unknown, quantity: unknown).This report is for a psi peek implant.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.H10 additional narrative: code 3191 used to capture required surgical intervention and device removal.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 or Problem Description
Updated event description: it was reported that on an unknown date, the psi peek implant had to be removed due to leakage, reports that there was no issue with the device.The procedure and patient outcome were unknown.This complaint involves three (3) devices.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5: updated event description.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.
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.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 history: part number: sd800.440.Lot number: h591696.Date of manufacture: 03/12/2018.Place of manufacture: brandywine.Part expiration date: n/a (non-sterile).List of non-conformances: none.Description of dhr review: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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 SD800.440 PEEK IMPLANT
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10164063
• Report Number: 2939274-2020-02874
• Device Sequence Number: 3300648
• Product Code: GXN
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: SD800.440
• Device Catalogue Number: SD800.440
• Device Lot Number: H591696
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 06/29/2020; 07/06/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 06/17/2020; 07/01/2020; 07/16/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES.; UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention