MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.442 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.442

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

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Investigation summary: part: sd800.442, lot: 5l70744, manufacturing site: (b)(4), release to warehouse date: 07.Aug.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

Device report from synthes, reports an event in (b)(6) as follows: it was reported that, on (b)(6) 2019, a peek implant had to be explanted in the patient due to a wound healing disorder.The original implantation occurred on (b)(6) 2019.No further information was provided.This complaint involves three (3) devices.This report is for one (1) psi sd800.442 peek implant.This is report is 1 of 3 for (b)(4).

• Brand Name: PSI SD800.442 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9182505
• MDR Text Key: 168775336
• Report Number: 8030965-2019-69286
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341685
• UDI-Public: (01)07611819341685
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.442
• Device Lot Number: 5L70744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention