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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.402 PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

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SYNTHES GMBH PSI SD800.402 PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE Back to Search Results
Catalog Number SD800.402
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown peek implant/unknown lot. Part and lot numbers are unknown; udi number is unknown. Patient identifier: (b)(6). Complainant part is not expected to be returned for manufacturer review/investigation. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent revision surgery to have peek implant removed due to infection on the left side. The infection was noticed several months after the initial surgery. The surgeon cut the plate and removed the left half of the plate. The surgery was successfully completed. A second revision surgery will be performed to insert new bone graft, new plate, and new peek implant. This report is for one (1) unknown peek implant. This is report 8 of 9 for (b)(4). This product complaint is related to (b)(4).
 
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Brand NamePSI SD800.402 PEEK IMPLANT
Type of DevicePLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11737005
MDR Text Key263529016
Report Number8030965-2021-03353
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K053199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSD800.402
Device Lot Number66P1773
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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