MAUDE Adverse Event Report: AAP IMPLANTATE AG 1/3 TUBULAR PLATE 3.5, 2 ROUND HOLES, L 29

Model Number PG 3513-02-2

Device Problems Crack (1135); Nonstandard Device (1420); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The plates affected by the recall are titanium 1 /3 tubular plate 3.5 - 2 round hole of the screw diameter 3.5 without a thread from our range of standard osteosynthesis implants.The item numbers and batches stated were manufactured out of specification.The relevant plates may have micro fissures which could impair mechanical stability.Batches other than those mentioned do not have this problem and are therefore not being recalled.Product description: 1/3 tubular plate 3.5, 2 round holes, l 29.Item number: pg 35313-02-2, lot: l002, product description: 1/3 tubular plate 3.5, 2 round holes, l 29, material: titanium; pg 3513-02-2, l006, 1/3 tubular plate 3.5, 2 round holes, l 29, titanium; pg 3513-02-2, l007, 1/3 tubular plate 3.5, 2 round holes, l 29, titanium; pg 3513-02-2, l008, 1/3 tubular plate 3.5, 2 round holes, l 29, titanium.

• Brand Name: 1/3 TUBULAR PLATE 3.5, 2 ROUND HOLES, L 29
• Type of Device: 1/3 TUBULAR PLATE 3.5, 2 ROUND HOLES, L 29
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg; berlin, 12099 ; GM 12099
• Manufacturer (Section G): AAP IMPLANTATE AG; lorenzweg 5; berlin, 12099 ; GM 12099
• Manufacturer Contact: denis kühn ; lorenzweg 5; 12099, 12099 ; GM 12099 ; 0307501919
• MDR Report Key: 6371111
• MDR Text Key: 69262312
• Report Number: 8043862-2017-00002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PG 3513-02-2
• Device Catalogue Number: PG 3513-02-2
• Device Lot Number: L002;L006;L007;L008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PG 3513-02-2 - 1/3 TUBULAR PLATE 3.5, 2 ROUND HOLE